BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK 8

    MDR report key: 11088826 · Received December 29, 2020

    Report

    Report Number
    2024168-2020-10970
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    December 9, 2020
    Report Date
    February 11, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION AND THROMBOSIS, AS LISTED IN THE MULTI-LINK 8 INSTRUCTIONS FOR USE, 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 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.E1: PHYSICIAN CONTACT. H6: HEALTH EFFECT CODE 2263 REMOVED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED: ON 12/09/2020, A SUBTOTAL OCCLUSION WITH THROMBUS WAS OBSERVED IN THE 2ND DIAGONAL CORONARY ARTERY, TARGET LESION. HEPARIN WAS PROVIDED AS STANDARD TREATMENT FOR ANOTHER PERCUTANEOUS CORONARY INTERVENTION AND A DRUG ELEUTING STENT WAS IMPLANTED AT THE TARGET LESION.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND A 100% STENOSED, 2ND DIAGONAL CORONARY ARTERY LESION. PRE-DILATATION WAS PERFORMED SUCCESSFULLY WITH A 2.0X15MM MINI TREK DILATATION CATHETER AND A 2.25X18MM MULTI-LINK STENT (1012164-18 9111441) WAS SUCCESSFULLY IMPLANTED IN THE 2ND DIAGONAL. POST-DILATATION WAS SUCCESSFULLY PERFORMED WITH A 2.5X8MM NC TREK. A NON-ABBOTT STENT (REBEL) WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX (CX) 80% STENOSED LESION. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN AND A NEW STEMI WAS DIAGNOSED. THE 2ND DIAGONAL WAS OBSERVED WITH 100% RESTENOSIS. THERE WAS NO DEVICE MALFUNCTION. AS TREATMENT, ANOTHER STENT WAS IMPLANTED. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552090 MULTI-LINK 8 CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 9111441

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R| S REBEL STENT| REBEL STENT