BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3040352 · Received April 8, 2013

    Report

    Report Number
    2024168-2013-02065
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 20, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - FEMORAL ANGIOGRAM NOT TAKEN. THE PROGLIDE INSTRUCTIONS FOR USE STATE: PERFORM A FEMORAL ANGIOGRAM THROUGH THE INTRODUCER SHEATH TO VERIFY THAT THE ACCESS SITE IS IN THE COMMON FEMORAL ARTERY. TO AVOID POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY, FLUOROSCOPICALLY EVALUATE THE FEMORAL ARTERY FOR SIZE, CALCIUM, TORTUOSITY, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL. (B)(4) - INDICATION FOR USE. THE PROSTAR XL 10 F SYSTEM IS DESIGNED FOR USE IN CONJUNCTION WITH 8.5 F TO 24 F SHEATHS. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED WITH A PROSTAR XL DEVICE IN THE COMMON FEMORAL ARTERY USING THE PERCLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE (TAVI) REPAIR. THE ARTERIOTOMY WAS 6 FR. REPORTEDLY, WHEN THE NEEDLES WERE BEING REMOVED FROM THE HUB, TWO NEEDLES WERE NOT CONNECTED TO THE SUTURE ENDS (WHITE). THE DEVICE WAS REMOVED AND A SECOND PROSTAR XL WAS DEPLOYED AND THE SUTURES SET ASIDE TO PERFORM THE INDEX PROCEDURE. THE SHEATH WAS UPSIZED TO AN 18F AND THE INDEX PROCEDURE WAS COMPLETED. AFTER COMPLETION OF THE TAVI PROCEDURE HEMOSTASIS WAS ACHIEVED WITH THE SUCCESSFULLY PRE-PLACED PROSTAR XL SUTURES. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY 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
    143267 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21015K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6 FR, 18 FRHEPARIN