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. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION REPORTED TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT IF ANY; 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. B3 - DATE OF EVENT: ESTIMATED D6- IMPLANT DATE IS ESTIMATED D4- THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. ATTACHMENT ARTICLE TITLED: "SIMULTANEOUS STENT IMPLANTATION FOR PULMONARY ARTERY BIFURCATION STENOSIS IN INFANTS".

Description of Event or Problem

IT WAS REPORTED IN A SUMMARY ARTICLE THE PROCEDURAL OUTCOMES OF SIMULTANEOUS STENT IMPLANTATION FOR PULMONARY ARTERY BIFURCATION STENOSIS IN INFANTS. THE MULTI-LINK VISION STENT WAS IMPLANTED IN 4 OF THE 17 PATIENTS IN THE STUDY. ALL PATIENTS REQUIRED PULMONARY ARTERY INTERVENTION AND RE-OPERATION. ADDITIONAL INFORMATION CAN BE FOUND IN THE SUMMARY ARTICLE, "SIMULTANEOUS STENT IMPLANTATION FOR PULMONARY ARTERY BIFURCATION STENOSIS IN INFANTS". NO ADDITIONAL INFORMATION WAS PROVIDED.