BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2132905 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04330
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED INCIDENT. IT WAS REPORTED THAT THE PROSTAR XL DEVICE WAS USED IN A CALCIFIED ARTERY. THE INSTRUCTIONS FOR USE (IFU) WHICH STATES UNDER SPECIAL PATIENT POPULATIONS INDICATES THAT THE SAFETY AND EFFECTIVENESS OF THE PROSTAR XL PVS SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. IT SHOULD BE NOTED THAT SUTURE MAY COME OUT OF THE ARTERY BECAUSE IT DID NOT CAPTURE THE TISSUE, OR DUE TO ANATOMICAL CONDITIONS SUCH AS FRAIL TISSUE. HOWEVER, WHETHER THIS PLAYED A ROLE IN THIS EVENT CANNOT BE CONFIRMED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INFORMATION PROVIDED AND THE REVIEW OF THE LOT HISTORY RECORD, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INFORMATION PROVIDED THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN TRAINING IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY AFTER AN ENDOVASCULAR ANEURYSM REPAIR-INSERTION OF ABDOMINAL GRAFT STENT PROCEDURE. REPORTEDLY, AFTER DEVICE DEPLOYMENT AND KNOT DELIVERING, THE ARTERIAL WALL WAS VERY FRAGILE AND DID NOT HOLD. THE SUTURES REPORTEDLY CAME OUT ATTACHED TO A SMALL PIECE OF ARTERIAL TISSUE. SURGICAL INTERVENTION WAS REQUIRED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 010356H

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention