MULTI-LINK 8

Description of Event or Problem

PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, ONE 3.5 X 15 MM MULTI-LINK 8 STENT WAS IMPLANTED IN THE HEAVILY CALCIFIED, PROXIMAL LEFT MAIN CORONARY ARTERY (LMCA) AND TWO 3.5 X 18 MM MULTI-LINK 8 STENTS WERE IMPLANTED IN THE MID AND PROXIMAL RIGHT CORONARY ARTERY. ON (B)(6) 2025, THE PATIENT PRESENTED WITH DYSPNEA ON EXERTION FOR DAYS WITH CHEST DISCOMFORT. MEDICATIONS (ISOSORBIDE DINITRATE, HEPARIN AND ANGIDIL) WERE GIVEN IN THE EMERGENCY ROOM. THE ELECTROCARDIOGRAM SHOWED AN ACUTE ANTERIOR INFARCTION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. UNDER THE TENTATIVE DIAGNOSIS OF NON-ST ELEVATION ACUTE CORONARY SYNDROME WITH ACUTE DECOMPENSATED HEART FAILURE, THE PATIENT WAS ADMITTED FOR FURTHER CARE. RESTENOSIS WAS NOTED IN THE MID RCA AND THE LEFT MAIN STENTS ONLY. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2025 IN THE STUDY TREATED LMCA AND THE MID RIGHT CORONARY ARTERY AND THE PROXIMAL LAD. THE PATIENT EXPIRED IN THE HOSPITAL ON (B)(6) 2025 FROM ISCHEMIC HEART FAILURE. IN THE OPINION OF THE PHYSICIAN, THE PATIENT'S DEATH WAS INDIRECTLY RELATED TO THE STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 UNTIL THE TIME OF HIS DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. THE REPORTED PATIENT EFFECTS OF ANGINA, OCCLUSION AND MYOCARDIAL INFARCTION ARE LISTED IN THE MULTI-LINK 8, MULTI-LINK 8 SMALL VESSEL (SV) AND MULTI-LINK LONG LENGTH (LL) CORONARY STENT SYSTEMS (CSS) INSTRUCTIONS FOR USE AND ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE 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. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.