BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3112404 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03037
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 3, 2013
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EXPERIENCE WAS CONFIRMED. THE VISUAL INSPECTION AND PERFORMANCE VERIFICATION ON THE RETURNED DEVICE DID NOT DETECT A QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED USING THE PROSTAR XL DEVICE IN A COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. THE ARTERIOTOMY WAS A 9F. REPORTEDLY, DURING NEEDLE DEPLOYMENT, THE HANDLE WAS ROTATED AND PULLED BACK; HOWEVER, THE PHYSICIAN FELT A RESISTANCE AFTER A FEW MILLIMETERS AND STOPPED PULLING THE HANDLE. A NEEDLE BACK-DOWN WAS PERFORMED AND THE PROSTAR XL DEVICES WAS REMOVED. AFTER PRE-PLACING THE SUTURES OF SECOND PROSTAR XL DEVICE USING THE PRECLOSE TECHNIQUE THE SHEATH WAS THEN UPSIZED TO AN 18F. THE TAVI PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED USING THE PRE-PLACED SUTURES OF THE SECOND PROSTAR XL DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS 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
    211859 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30208K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 9F, 18F, HEPARIN