BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3891129 · Received June 24, 2014

    Report

    Report Number
    2024168-2014-04027
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF OCCURRENCE. INCIDENT OCCURRED IN (B)(6) 2014. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE TWO OTHER PROSTAR DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED UNKNOWN DEVICE FAILURE EVENT WAS CONFIRMED. DEVICE ANALYSIS FOUND THE COILED SUTURE LUMENS HAD BEEN DETACHED AND NOT RETURNED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NON-CONFORMING MATERIAL REPORTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED WITH THREE PROSTAR XL DEVICES, VIA AN 8F SHEATH USING A PRE-CLOSE TECHNIQUE, PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, NO BLOOD FLOW WAS SEEN AT THE LUMEN MARKER OF THE FIRST PROSTAR XL DEVICE. ON THE SECOND DEVICE THE LEVER APPEARED TO HAVE BEEN USED BEFORE THE INTERVENTION TOOK PLACE. AN UNKNOWN DEVICE FAILURE OCCURRED WITH A THIRD PROSTAR XL DEVICE. THE SUTURES OF A FOURTH PROSTAR XL DEVICE WERE SUCCESSFULLY PLACED USING THE PRE-CLOSE TECHNIQUE. THE SHEATH WAS UPSIZED TO 18F AND THE TAVI PROCEDURE WAS COMPLETED. THE PRE-PLACED SUTURES OF THE FOURTH PROSTAR XL DEVICE WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN REPORTEDLY IS TRAINED IN THE USE OF THE PROSTAR XL DEVICE AND ESTABLISHED IN THE LARGE HOLE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367287 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40219K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8F, 18F, HEPARIN