BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2103121 · Received May 25, 2011

    Report

    Report Number
    2024168-2011-03689
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    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. THE FIRST PROSTAR XL IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION FOUND THAT THE DEVICE WAS RETURNED FULLY DEPLOYED. THE NEEDLES AND SUTURES WERE NOT RETURNED. WITHOUT THE RETURN OF THE SUTURES, THE ANALYSIS WAS LIMITED. THE HUB, HANDLE, MARKER LUMEN, SUTURE LUMENS, INTER-LOCK, BARREL AND SHEATH COMPONENTS WERE EXAMINED AND FOUND TO BE WITHIN SPECIFICATIONS AND UNDAMAGED. DURING TESTING, THE HANDLE WAS FULLY DEPLOYED AND THEN BACKED DOWN AND LOCKED AND THE INTER-LOCK WAS ROTATED, BOTH FUNCTIONED NORMALLY. BASED ON THE ANALYSIS OF THE RETURNED COMPONENTS THE REPORTED SUTURE BREAK EXPERIENCED DURING USE COULD NOT BE CONFIRMED. IT WAS REPORTED THAT THE ARTERIOTOMY WAS HEAVILY CALCIFIED, AND MAY HAVE BEEN A CONTRIBUTING FACTOR BASED ON THE GUIDANCE IN THE INSTRUCTION FOR USE (IFU) WHICH STATES: THE SAFETY AND EFFECTIVENESS OF THE PROSTAR XL DEVICE HAS NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. BASED ON THE INVESTIGATION FINDINGS, THE CAUSE OF THE REPORTED SUTURE BREAK COULD NOT BE DETERMINED AS THE REPORTED EXPERIENCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD FOR THIS LOT DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS INCIDENT. THERE WERE NO MANUFACTURING OR QUALITY DEFICIENCIES DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED TO PERFORM PRE-CLOSURE PLACEMENT OF THE SUTURES IN A HEAVILY CALCIFIED COMMON FEMORAL ARTERY PRIOR TO A CARDIAC VALVE POSITIONING PROCEDURE. REPORTEDLY, THE NEEDLES DID NOT PRESENT THEMSELVES. A SECOND PROSTAR XL WAS USED; HOWEVER, A SUTURE BREAK OCCURRED. THE PUNCTURE SITE WAS SUTURED CLOSED FOLLOWING THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, 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 020216H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: PILOT 150SHEATH: 20 F