Events

INNOVA™ 180 mm & 200 mm SELF-EXPANDING STENT SYSTEM 의 안전성 경고

Food and Drug Administration Philippines에 따르면, 해당 안전성 경고 는 Philippines 에서 Boston Scientific Philippines, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 연번
    2018-043
  • 사례 국가
    Philippines
  • 사례 출처
    FDAP
  • 사례 출처 URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/488555-fda-advisory-no-2018-043-voluntary-recall-of-innova-180-mm-200-mm-self-expanding-stent-system
  • 비고 / 경고
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • 데이터 추가 비고
  • 원인
    Fda advisory no. 2018-043 voluntary recall of innova™ 180 mm & 200 mm self-expanding stent system all are hereby advised by the food and drug administration (fda) about the voluntary recall of innovatm stent system with attached sizes distributed by boston scientific philippines, inc., with business address at unit 2503 antel global corporate center, julia vargas, avenue, ortigas center, pasig city 1605 with the following information: the cited medical device was voluntarily recalled by boston scientific philippines, inc. after partial deployment occurs when the stent is unable to be fully released from the delivery system. part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery system. the most common reported injury has been additional medical or minor surgical intervention, vessel trauma or prolongation of the implant procedure. in certain cases boston scientific philippines, inc. received reports of major surgery to retrieve the stent/delivery system or to correct vascular compromise. distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested.   attachments: fda advisory no. 2018-043.Pdf.

Device

INNOVA™ 180 mm & 200 mm SELF-EXPANDING STENT SYSTEM

Manufacturer

Boston Scientific Philippines, Inc.
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    FDAP