BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1302508 · Received February 2, 2009

    Report

    Report Number
    2953144-2009-00135
    Event Type
    Injury
    Date Received
    February 2, 2009
    Date of Event
    September 1, 2006
    Report Date
    January 19, 2009
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVAL. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ATTACHMENT: DR. J. WATELET, PHD, ET AL; "PERCUTANEOUS REPAIR OF AORTIC ANEURYSMS: A PROSPECTIVE STUDY OF SUTURE-MEDIATED CLOSURE DEVICES." SEE SCANNED PAGES.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: MISSING SUTURE. TIME OF SYMPTOMS/AE: DURING PROCEDURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS/PSEUDOANEURYSM/SURGICAL REPAIR. THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A PROSPECTIVE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VESSEL CLOSURE (PRE-CLOSE TECHNIQUE) AFTER TOTAL PERCUTANEOUS PLACEMENT OF ABDOMINAL AND THORACIC AORTIC ENDOGRAFTS USING THE PROSTAR XL SUTURE-MEDIATED CLOSURE SYSTEM. FROM 2002 TO 2005, 29 PTS UNDERWENT ENDOVASCULAR REPAIR. A 58 PROSTAR XL 8F (TWO 8F TO CLOSE 22-24F EACH ACCESS SITE) AND 18 PROSTAR XL 10F (TO CLOSE 16F ACCESS SITES). THERE WERE SEVEN PERIPROCEDURAL EVENTS IN ACHIEVING HEMOSTASIS IN SEVEN PTS. REASONS FOR FAILURES WERE IDENTIFIED IN FOUR CASES: FEMORAL CALCIFICATIONS UNDER ESTIMATED BY THE DUPLEX SCAN IN ONE CASE AND MISSING SUTURES IN TWO CASES. IN ONE CASE, A NEEDLE WAS DEFLECTED THROUGH THE SKIN BY A CALCIFIED PLAQUE. THESE FAILURES RESULTED IN THREE PERIPROCEDURAL EXPOSURES OF THE ACCESS ARTERY FOR SURGICAL REPAIR, ONE PSEUDOANEURYSM WHICH OCCURRED AT DAY 3 AND SPONTANEOUSLY HEALED, THREE BLEEDS WHICH SPONTANEOUSLY HEALED FOLLOWING PROLONGED COMPRESSION AND ONE MINOR BLEED OCCURRED AT DAY 2 REQUIRING ADDITIONAL COMPRESSION. ONE DELAYED BLEED OCCURRED AT DAY 9 AND WAS TREATED BY SURGICAL INTERVENTION TO REPAIR THE FEMORAL ARTERY. DESPITE ACCESS COMPLICATION IN THESE CASES, COMPLETE PERCUTANEOUS REPAIR WAS ACHIEVED. ALL COMPLICATIONS EXCEPT TWO (DELAYED BLEEDING AT DAY 9 AND PSEUDOANEURYSM AT DAY 3) OCCURRED DURING THE PROCEDURE ITSELF, REQUIRING IMMEDIATE TREATMENT WITH SURGICAL EXPOSURE OF THE ACCESSED ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74.9 YR Required Intervention 8TALENT (MEDTRONIC)| ENDOGRAFTS: 21 ZENITH (COOK)| PERCLOSE PROSTAR XL 10FR| 1 ANEURX (MEDTRONIC)