BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2840661 · Received November 20, 2012

    Report

    Report Number
    2024168-2012-07329
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE OF THE NEEDLES TO DEPLOY WAS CONFIRMED AS ANALYSIS OF THE DEVICE DETECTED A NEEDLE STRIKE MARK ON THE BARREL THAT INDICATED NEEDLE TRAJECTORY HAD DEVIATED FROM ITS INTENDED PATH INTO THE BARREL NEEDLE LUMEN, STRUCK THE BARREL, AND STOPPED FURTHER NEEDLE DEPLOYMENT. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, 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.

    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 LEFT 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.

    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 LEFT 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. THE NEEDLES WERE SUCCESSFULLY BACKED DOWN AND THE SUTURES OF A SECOND PROSTAR XL DEVICE WERE DEPLOYED AND SET TO THE SIDE. THE ACCESS SITE WAS DILATED TO 17-FRENCH TO MATCH THE OUTER DIAMETER OF THE DELIVERY CATHETER. AFTER CONCLUSION OF THE EVAR PROCEDURE, THE KNOTS FROM THE PROSTAR XL DEVICE WERE SEQUENTIALLY ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. 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: 17-FRENCH| SHEATH: 10-FRENCH. HEPARIN