MULTI-LINK VISION

Additional Manufacturer Narrative

THE DEVICES WERE 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 NUMBERS AND/OR LOT NUMBERS WERE NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. 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. THE REPORTED PATIENT EFFECTS OF ARRHYTHMIA, MYOCARDIAL INFARCTION AND THROMBOSIS, ARE LISTED IN THE VISION CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

Description of Event or Problem

THE STUDY CONDUCTED TO TO A ANALYZE THE IMPACT OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) AS THE CULPRIT VESSEL OF THE ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) ON VERY-TERM OUTCOME PATIENTS UNDERGOING PRIMARY PCI WITH XIENCE V STENTS AND MULTILINK VISION STENT ENROLLED IN THE EXAMINATION-EXTEND STUDY (10-YEAR FOLLOW-UP OF THE EXAMINATION TRIAL) . PATIENT'S WERE SEPARATED INTO GROUPS LAD-RELATED STEMI AND NON-LAD-RELATED STEMI. AT THE 0 TO 1 YEAR ANALYSIS BOTH GROUPS NOTED (DEATH, VENTRICULAR ARRHYTHMIAS, CARDIOGENIC SHOCK, STENT THROMBOSIS, TARGET LESION REVASCULARIZATION (TLR). AT THE 10 YEAR OUTCOME BOTH GROUPS NOTED (CARDIAC DEATH, MYOCARDIAL INFRACTION, REVASCULARIZATION, MYOCARDIAL INFRACTION, STENT THROMBOSIS. THERE WERE NO DIFFERENCES IN PATIENT-ORIENTED COMPOSITE ENDPOINT (POCE) BETWEEN LAD AS THE STEMI-RELATED CULPRIT VESSEL AND OTHER VESSELS AT THE 10 YEARS FOLLOW-UP. HOWEVER, IT WAS NOTED ALL CAUSE MORTALITY WAS MORE COMMON IN THE LAD-STEMI GROUP WITHIN THE FIRST YEAR. SPECIFIC PATIENT INFORMATION REMAINS UNKNOWN. ADDITIONAL INFORMATION CAN BE FOUND IN THE ATTACHED ARTICLE "LONG-TERM PROGNOSTIC IMPACT OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY AS THE STEMI-RELATED CULPRIT VESSEL: SUBANALYSIS OF THE EXAMINATION-EXTEND TRIAL". NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3, B6, D6: DATES ESTIMATED: D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ATTACHMENT: ARTICLE TITLE: "LONG-TERM PROGNOSTIC IMPACT OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY AS THE STEMI-RELATED CULPRIT VESSEL: SUBANALYSIS OF THE EXAMINATION-EXTEND TRIAL"