BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3313521 · Received August 28, 2013

    Report

    Report Number
    2024168-2013-05460
    Event Type
    Injury
    Date Received
    August 28, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ESTIMATED DATE OF OCCURRENCE WAS ENTERED AS (B)(4) 2013. DAHDOUH Z.; ROULE V.; GROLLIER G., (HEART (HEART) (UNITED KINGDOM) AUGUST 1, 2013, 99/16 (1217-1218)): LIFE-THREATENING ILIAC ARTERY RUPTURE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI): DIAGNOSIS AND MANAGEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. THE ARTICLE IS A RETROSPECTIVE REVIEW OF LIFE-THREATENING ILIAC ARTERY RUPTURE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI): DIAGNOSIS AND MANAGEMENT. IT WAS NOTED IN THE ARTICLE THAT THE PROSTAR XL DEVICE WAS USED DURING THIS PROCEDURE. THE PROCEDURE TOOK PLACE BY RIGHT TRANSFEMORAL ACCESS USING A PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM. AFTER THE DEPLOYMENT OF THE STENTED VALVE, AND THE RETRIEVAL OF THE DELIVERY SYSTEM, ACUTE HAEMODYNAMIC DETERIORATION OCCURRED. ABDOMINAL AORTIC ANGIOGRAPHY IDENTIFIED MASSIVE CONTRAST MEDIA EXTRAVASATION AT THE LEVEL OF THE RIGHT EXTERNAL ILIAC ARTERY. AN NON-ABBOTT OCCLUSIVE BALLOON WAS QUICKLY INSTALLED BY CONTRALATERAL FEMORAL ACCESS AND WAS DEPLOYED IN THE RIGHT COMMON ILIAC ARTERY TO LIMIT ACTIVE BLEEDING, THE BREACH WAS COMPLETELY CLOGGED WITH TWO NON-ABBOTT COVERED STENTS AND BLEEDING CEASED. WE BELIEVE THAT THE PROSTAR DEVICE WAS NOT RELATED AND DID NOT CONTRIBUTED TO THE ARTERY RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423888 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention STENT:BARD FLUENCY VASCULAR STENT GRAFT 10/80 (X2)