BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2840645 · Received November 20, 2012

    Report

    Report Number
    2024168-2012-07328
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 30, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE RIGHT COMMON FEMORAL ARTERY WAS REPORTEDLY HEAVILY CALCIFIED. THE PROSTAR XL INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED, IN PATIENTS WITH COMMON FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE OF THE NEEDLES TO DEPLOY WAS NOT CONFIRMED AS ANALYSIS OF THE DEVICE DID NOT DETECT ANY DAMAGE OR ANOMALY OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN A 10-FRENCH SIZED HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A PROSTAR XL DEVICE. REPORTEDLY, HOLDING THE DEVICE HELD AT AN ANGLE OF 45 DEGREES TO THE LONGITUDINAL PLANE OF THE ARTERY, THE HANDLE OF THE DEVICE WAS PULLED TO DEPLOY THE NEEDLES, BUT ONLY THREE OF THE FOUR NEEDLES PRESENTED AT THE HUB OF THE DEVICE. TENSION WAS APPLIED TO THE SUTURES TO GET THEM BACK INTO THE DEVICE. ALTHOUGH DIFFICULTY WAS ENCOUNTERED DURING BACKDOWN OF THE NEEDLES BACK INTO THE PROSTAR SHEATH, THE NEEDLES WERE SUCCESSFULLY BACKEDDOWN. IT WAS NOT POSSIBLE TO GET THE SUTURES ALL THE WAY BACK IN THE SYSTEM. THE PROSTAR XL DEVICE WAS REMOVED, BUT BECAUSE A LARGE AMOUNT OF BLOOD LEAKED FROM THE ACCESS SITE, IT WAS NOT POSSIBLE TO USE ANOTHER PROSTAR XL DEVICE. THE BLOOD LEAK WAS MANAGED AND AFTER SUCCESSFUL EVAR PROCEDURE, A SURGICAL CUT DOWN WAS PERFORMED AND THE VESSEL WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. THE EVAR PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHESIA. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROSTAR XL DEVICE. 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 20710K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 10-FRENCH. HEPARIN