BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1321800 · Received February 20, 2009

    Report

    Report Number
    2024168-2009-00279
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    January 23, 2009
    Report Date
    January 26, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: SEPARATED BALLOON AND STENT IMPLANT REMAINS IN THE PATIENT'S ANATOMY, WHICH IS CONSIDERED TO BE PERMANENT INJURY OR IMPAIRMENT. DEVICE ISSUE: BALLOON AND STENT IMPLANT SEPARATION. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANTERIOR TIBIAL ARTERY. DURING ADVANCEMENT OF A 3.0X18MM VISION STENT DELIVERY SYSTEM (SDS), THERE WAS RESISTANCE WITH THE GUIDE WIRE; HOWEVER, THE SDS WAS ADVANCED TO THE LESION AGAINST RESISTANCE. UPON INFLATION, THE BALLOON DID NOT INFLATE, AND IT WAS NOTED THAT THE BALLOON WITH THE STENT IMPLANT HAD SEPARATED FROM THE SDS. THE SDS WAS THEN REMOVED AND, THE SEPARATED BALLOON AND STENT REMAINED AT THE LESION SITE. ANOTHER COMPANY'S SDS WAS USED TO PUSH THE SEPARATED BALLOON AND STENT IMPLANT OUT OF THE LESION SITE AND THE OTHER COMPANY'S STENT WAS DEPLOYED AT THE LESION. FLUOROSCOPY REVEALED THAT THE SEPARATED BALLOON AND STENT WERE IN THE POSTERIOR TIBIAL ARTERY JUST ABOVE THE FOOT. AFTER CONSULTATION WITH A VASCULAR SURGEON, IT WAS DETERMINED THAT THE SEPARATED BALLOON AND STENT DID NOT NEED TO BE REMOVED. THEREFORE, THE SEPARATED BALLOON AND STENT REMAIN IN THE PATIENT'S ANATOMY. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8112741

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability GUIDE WIRE: BMW GUIDE WIRE| STENT: 3.0X18MM (X2)| DRIVER: 3.0 X 18 MM