BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK TETRA CORONARY STENT SYSTEM

    MDR report key: 1132133 · Received August 21, 2008

    Report

    Report Number
    2024168-2008-00701
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THE DEVICE WAS NOT RETURNED TO ABBOTT VASCULAR FOR EVALUATION. AS LISTED IN THE INSTRUCTIONS FOR USE, RESTENOSIS OF THE STENTED SEGMENT IS A KNOWN ADVERSE EFFECT ASSOCIATED WITH CORONARY STENTING. THIS KNOWN PATIENT EFFECT IS NOT NECESSARILY AN INDICATION OF A QUALITY ISSUE. IN THIS CASE, THE SDS WAS IMPLANTED ABOUT EIGHT YEARS AGO AND THERE WAS NO DEVICE MALFUNCTION REPORTED AT THE TIME OF THE PROCEDURE. THE ROOT CAUSE OF THE RESTENOSIS IS UNKNOWN, BUT THERE IS NO INDICATION OF A QUALITY ISSUE.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT IN A PROCEDURE ABOUT EIGHT YEARS AGO (2000) INVOLVING MULTIPLE DEVICES AND DIFFERENT PARTS OF THE ANATOMY, AN UNKNOWN TETRA STENT DELIVERY SYSTEM (SDS) WAS PLACED IN THE RIGHT CORONARY ARTERY (RCA). IN 2008, THE PATIENT WAS REPORTEDLY PRESENTED WITH IN-STENT RESTENOSIS. REPORTEDLY, A XIENCE SDS WAS UTILIZED IN TREATING THE RESTENOSIS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK TETRA CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention VIATRAC| DILATATION CATHETER: MAVERICK X 2| GUIDING CATHETER: BENTSON| TAD2| GUIDE WIRE: BALANCE MIDDLEWEIGHT WIRE| OTHER: BIVALIRUDIN| SHEATH: SHUTTLE SHEATH