MULTI-LINK VISION

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED, AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF STENOSIS IS LISTED IN THE VISION CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. ATTACHMENT ARTICLE TITLED "NEONATAL PDA STENT CONSIDERATIONS: RETROSPECTIVE REVIEW OF ANTICOAGULATION, STENT TYPE, AND PA JAILING". B3: ESTIMATED DATE D4- THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6A- ESTIMATED DATE. THE ADDITIONAL DEVICE AND THE PATIENT DEATH REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

Description of Event or Problem

IT WAS REPORTED IN A SUMMARY ARTICLE THAT EVALUATED THE IMPACTS OF NEONATES WHO UNDERWENT PATENT DUCTUS ARTERIOSUS (PDA) STENTING FOR DUCTAL-DEPENDENT PULMONARY BLOOD FLOW WHICH REVIEWED THE ANTICOAGULATION STRATEGY, STENT TYPE, AND PULMONARY ARTERY (PA) JAILING ON UNPLANNED REINTERVENTION RATES AND PA GROWTH. A TOTAL OF 118 NEONATES SUCCESSFULLY UNDERWENT PDA STENTING WITH EITHER A MULTI-LINK VISION STENT OR A XIENCE STENT. OF THESE, 116 HAD UNPLANNED REINTERVENTION DUE TO CYANOSIS SECONDARY TO IN-STENT STENOSIS OF THE PREVIOUSLY PLACED PDA STENT. ADDITIONALLY, 11 PATIENTS DIED DURING THE FOLLOW-UP PERIOD. ADDITIONAL INFORMATION CAN BE FOUND IN THE SUMMARY ARTICLE, "NEONATAL PDA STENT CONSIDERATIONS: RETROSPECTIVE REVIEW OF ANTICOAGULATION, STENT TYPE, AND PA JAILING".