BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK 8

    MDR report key: 19705749 · Received July 9, 2024

    Report

    Report Number
    2024168-2024-08083
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 24, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MAF
    UDI-DI
    08717648131493
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. BASED ON THE COMPLAINT REVIEW, THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. THE REPORTED PATIENT EFFECTS OF ANGINA, ARRHYTHMIA, ISCHEMIA, AND STENOSIS, AS 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 (IFU), 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 SUBSEQUENT SURGICAL INTERVENTION AND UNEXPECTED MEDICAL INTERVENTION (ADDITIONAL THERAPY/NON-SURGICAL 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.

    Description of Event or Problem · 0

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT STENTING WITH THREE MULTI-LINK 8 STENTS (3.0X38MM IN THE PROXIMAL LEFT MAIN CORONARY ARTERY (LMCA), A 3.0X38 IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND A 2.5X38MM IN THE DISTAL RCA). ON (B)(6) 2024 THE PATIENT SUFFERED FROM INTERMITTENT CHEST TIGHTNESS ON EXERTION, ASSOCIATED WITH DYSPNEA AND PALPITATIONS. THALLIUM SCANS REVEALED LARGE EXTENT OF STRESS-INDUCED ISCHEMIA IN THE MYOCARDIUM. UNDER IMPRESSION OF CORONARY ARTERY DISEASE PERCUTANEOUS CORONARY INTERVENTION RESTENOSIS WAS SUSPECTED. THE PATIENT WAS ADMITTED FOR CATHETERIZATION ON (B)(6) 2024. ON (B)(6) 2024, 90% RESTENOSIS WAS OBSERVED IN THE LMCA AND 99% STENOSIS WAS OBSERVED IN THE PROXIMAL AND DISTAL RCA; THE THREE MULTI-LINK 8 STENTS HAD RESTENOSIS. CORONARY ARTERY BYPASS GRAFTING (CABG) WAS PERFORMED ON 6/28/2024. THE PATIENT REMAINS HOSPITALIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459934 MULTI-LINK 8 STENT, CORONARY MAF ABBOTT VASCULAR INC. 1012165-38 2120141 08717648131493

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R| S MULTI-LINK 8 STENT 3.0X38.| MULTI-LINK 8 STENT 3.0X38.