MULTI-LINK VISION

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"

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(S) OF DEATH AND STENOSIS ARE 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 DEATH, 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" B2, 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 ADDITIONAL PATIENT ADVERSE EFFECTS REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.