ACS RX MULTI-LINK¿ CORONARY STENT SYSTEM

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. HE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION 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. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF THROMBOSIS/THROMBUS AND MYOCARDIAL INFARCTION, 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. B2, ESTIMATED DATE. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6: ESTIMATED DATE. THE ADDITIONAL PATIENT EFFECT OF DEATH REPORTED N B5 IS CAPTURED UNDER A SEPARATE MEDWATCH REPORT. ATTACHMENT ARTICLE TITLED "IMPACT OF DIABETES ON 10-YEAR OUTCOMES FOLLOWING ST-SEGMENT¿ ELEVATION MYOCARDIAL INFARCTION: INSIGHTS FROM THE EXAMINATION-EXTEND TRIAL"

Description of Event or Problem

IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE V AND MULTI-LINK STENTS THAT MAY BE RELATED TO THE FOLLOWING: ALL-CAUSE DEATH, MYOCARDIAL INFARCTION, ANY REVASCULARIZATION WITH PROLONG HOSPITALIZATION AND STENT THROMBOSIS. DETAILS ARE LISTED IN THE ARTICLE, TITLED, "IMPACT OF DIABETES ON 10-YEAR OUTCOMES FOLLOWING ST-SEGMENT¿ ELEVATION MYOCARDIAL INFARCTION: INSIGHTS FROM THE EXAMINATION-EXTEND TRIAL"