LivaNova Perceval Sutureless Heart Valve 의 안전성 경고

Safety alert

2018-06-25

2018-06-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180625b.html

Medical device safety alert: livanova perceval sutureless heart valve medical device manufacturer, livanova, has issued a medical device safety alert concerning its perceval sutureless heart valve. the affected products are identified as follow: perceval sutureless aortic heart valve size s, item number: icv1208, reference: pcs21 perceval sutureless aortic heart valve size m, item number: icv1209, reference: pvs23 perceval sutureless aortic heart valve size l, item number: icv1210, reference: pvs25 perceval sutureless aortic heart valve size xl, item number: icv1211, reference: pvs27 the manufacturer has recently become aware, through its post-market surveillance processes, of more than anticipated cases of valve insufficiency, primarily caused by oversizing leading to “stent folding”, which is defined as an inward deformation of the stent at the annulus level. according to the manufacturer, in the past 10 years, 49 complaints related to perceval folding were reported, with an increase in the number of cases in 2017. although the event has been observed with all prosthesis sizes, it has been more frequently reported with sizes s and m. moreover, patients with an implanted perceval valve may experience valve folding when emergency cardiovascular procedures, such as cardiopulmonary resuscitation, are administered post-implant. the manufacturer will be providing clarifications about this potential adverse event related to the perceval valve and recommendations to prevent its occurrence. it will have an in-person meeting with the physicians implanting perceval to discuss key procedural steps to be followed to reduce the occurrence of stent folding, and to provide further information for an early detection of the phenomenon. there are no required actions for patients already implanted with perceval outside of normal monitoring and treatment. in the meantime, the affected users are reminded of the importance of the following key points, as indicated in the instructions for use (ifu), for prevention and early detection of stent folding: prevention decalcification, to avoid uneven surfaces; correct sizing, using available information in the ifu; ballooning, with the recommendation to pour warm sterile saline (at 37°c) while ballooning. early detection visual inspection, checking that the perceval stent is correctly deployed; performing an intraoperative echographic evaluation after perceval implant to confirm correct positioning and verify valve functionality under beating heart conditions. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 june 2018.