ACS RX MULTI-LINK¿ CORONARY STENT SYSTEM

Description of Event or Problem

IT WAS REPORTED IN AN ARTICLE SUMMARY THAT SHORT-TERM OUTCOMES FOLLOWING ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) IN WOMEN ARE WORSE THAN IN MEN, WITH A HIGHER MORTALITY RATE. IT IS UNKNOWN WHETHER SEX PLAYS A ROLE IN VERY LONG-TERM OUTCOMES. THE AIM OF THIS STUDY WAS TO ASSESS WHETHER VERY LONG-TERM OUTCOMES FOLLOWING STEMI TREATMENT ARE INFLUENCED BY SEX. THE EXAMINATION-EXTEND (10-YEAR FOLLOW-UP OF THE EXAMINATION TRIAL) WAS AN INVESTIGATOR-DRIVEN 10-YEAR FOLLOW-UP OF THE EXAMINATION (A CLINICAL EVALUATION OF EVEROLIMUS ELUTING CORONARY STENTS IN THE TREATMENT OF PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION) TRIAL, WHICH RANDOMLY 1:1 ASSIGNED 1,498 PATIENTS WITH STEMI TO RECEIVE EITHER EVEROLIMUS-ELUTING STENTS (XIENCE V) OR BARE-METAL STENTS (MULTI-LINK). THE PRESENT STUDY WAS A SUBANALYSIS ACCORDING TO SEX. THE PRIMARY ENDPOINT WAS THE COMPOSITE PATIENT-ORIENTED ENDPOINT (ALL-CAUSE DEATH, ANY MYOCARDIAL INFARCTION, OR ANY REVASCULARIZATION) AT 10 YEARS. SECONDARY ENDPOINTS WERE THE INDIVIDUAL COMPONENTS OF THE PRIMARY ENDPOINT, CARDIAC DEATH, TARGET VESSEL MYOCARDIAL INFARCTION, TARGET LESION REVASCULARIZATION, AND STENT THROMBOSIS. AMONG 1,498 PATIENTS WITH STEMI, 254 (17%) WERE WOMEN. OVERALL, WOMEN WERE OLDER, WITH MORE ARTERIAL HYPERTENSION AND LESS SMOKING HISTORY THAN MEN. AT 10 YEARS, NO DIFFERENCE WAS OBSERVED BETWEEN WOMEN AND MEN FOR THE PATIENT-ORIENTED COMPOSITE ENDPOINT. THERE WAS A TREND TOWARD HIGHER ALL-CAUSE DEATH IN WOMEN VS MEN, WITH NO DIFFERENCE IN CARDIAC DEATH OR OTHER ENDPOINTS. AT VERY LONG-TERM FOLLOW-UP, THERE WERE NO DIFFERENCES IN THE COMBINED PATIENT-ORIENTED ENDPOINT BETWEEN WOMEN AND MEN, WITH A TREND TOWARD HIGHER ALL-CAUSE DEATH IN WOMEN NOT DRIVEN BY CARDIAC DEATH. THE PRESENT FINDINGS UNDERLINE THE NEED FOR FOCUSED PERSONALIZED MEDICINE IN WOMEN AFTER PERCUTANEOUS REVASCULARIZATION AIMED AT BOTH CARDIOVASCULAR AND SEX-SPECIFIC RISK FACTOR CONTROL AND TARGETED TREATMENT. ADDITIONAL INFORMATION CAN BE FOUND IN THE ARTICLE "SEX DIFFERENCES IN 10-YEAR OUTCOMES FOLLOWING STEMI A SUBANALYSIS FROM THE EXAMINATION-EXTEND TRIAL".

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B2, B3: ESTIMATED DATE. C4: TREATMENT/THERAPY START DATE IS ESTIMATED. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6: DATE OF IMPLANT IS ESTIMATED. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS.

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. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF THROMBOSIS/THROMBUS, MYOCARDIAL INFARCTION AND 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. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE MULTI-LINK 8, MULTI-LINK 8 SV UND MULTI-LINK 8 LL CORONARY STENT SYSTEM, INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. 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.