BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2001733 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01207
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (CONCOMITANT MEDICAL PRODUCTS): SHEATH: 24 FR OTHER: TAG THORACIC ENDOPROSTHESIS(GORE), INTRODUCER GORE 24 FR. (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROSTAR XL DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY (CFA) AFTER PLACEMENT OF A THORACIC ENDOPROSTHESIS. REPORTEDLY, DURING PRE-CLOSURE, THE PROSTAR DEVICE WAS PLACED, THE NEEDLES DEPLOYED AND THE SUTURES WERE LEFT ASIDE. THE GRAFT WAS PLACED IN THE AORTA AND THE 24 FR SHEATH WAS REMOVED. VESSEL CLOSURE WAS ATTEMPTED BY ADVANCING THE KNOTS WITHOUT COMPLICATIONS, HOWEVER ARTERIAL BLEEDING WAS STILL OBSERVED. A DECISION WAS MADE TO SURGICALLY CLOSE THE ACCESS SITE, AND AT THAT TIME, A TEAR AT THE CFA WAS NOTICED. THE TEAR AND THE ACCESS SITE WERE REPAIRED/SUTURED USING A PROLENE SUTURE. THE VASCULAR SURGEON INDICATED THAT THE TEAR WAS ATTRIBUTED TO THE 24 FR SHEATH REMOVAL FROM THE ARTERIOTOMY AND RULED OUT THAT THE VESSEL CLOSURE DEVICE CONTRIBUTED TO IT. A FEMORAL ANGIOGRAM WAS NOT TAKEN. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 900036H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention