BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO LL PERIPHERAL SELF EXPANDING STENT SYSTEM

    MDR report key: 1979530 · Received February 4, 2011

    Report

    Report Number
    2024168-2011-00694
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    December 12, 2010
    Report Date
    January 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THROMBOSIS IS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ESTIMATED REPORTED WEIGHT.

    Additional Manufacturer Narrative · 1

    (B)(4). ANGIOGRAPHIC IMAGES WERE REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE RESULTS CONCLUDED THAT THE STENTS IN THE COMMON FEMORAL ARTERY DOWN TO THE POPLITEAL ARTERY APPEAR PATENT AND MOSTLY CLEAR POST DILATATION. THERE APPEARS TO BE SOME THROMBUS ALONG THE PERIMETER OF THE STENTS THROUGHOUT, BUT NO OCCLUSION IS NOTED IN THE FINAL POST FILMS.

    Additional Manufacturer Narrative · 1

    (B)(4). ABSOLUTE PRO LL PERIPHERAL SELF-EXPANDING STENT SYSTEM (PART #1012009-150, LOT #9110652) CORRECTION - PART/LOT NUMBER CHANGED FROM UNK TO 1012008-150/9112551. PROCEDURAL ANGIOGRAPHIC IMAGES AND THE PART AND LOT NUMBER WERE PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ABSOLUTE PRO LL PERIPHERAL SELF-EXPANDING STENT SYSTEM (PART #1012009-150, LOT #9110652) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST A STENTING PROCEDURE WITH AN ABSOLUTE STENT, IN STENT THROMBOSIS WAS IDENTIFIED REQUIRING THROMBOLYTIC MEDICATION AND PERCUTANEOUS ANGIOPLASTY. THIS THROMBOSIS OCCURRED WHEN THE PATIENT CEASED TAKING PLAVIX. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT A SECOND ABSOLUTE PRO STENT WAS IMPLANTED OVERLAPPING THE REPORTED STENT. THE STENTS WERE DEPLOYED IN THE COMMON FEMORAL ARTERY TO THE POPLITEAL ARTERY. IN-STENT THROMBOSIS WAS ALSO IDENTIFIED IN THE SECOND STENT. BOTH STENTS WERE SUCCESSFULLY TREATED WITH THROMBOLYTIC MEDICATION AND PERCUTANEOUS ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO LL PERIPHERAL SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 9112551

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention