BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2211902 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05736
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 PROSTAR XL DEVICE NEEDLES WERE REDEPLOYED AFTER BEING BACKED-DOWN. THE INSTRUCTIONS FOR USE STATE UNDER TECHNIQUE FOR NEEDLE BACK-DOWN STEP #9, DO NOT ATTEMPT TO REDEPLOY THE PROSTAR XL DEVICE AFTER THE NEEDLES GAVE BEEN BACKED-DOWN. REPLACE THE PROSTAR XL WITH ANOTHER PROSTAR XL DEVICE, AN INTRODUCER SHEATH, OR UTILIZE CONVENTIONAL COMPRESSION THERAPY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE HANDLE REMAINED IN THE NEEDLE BACK-DOWN POSITION. THE NEEDLES AND SUTURES WERE NOT RETURNED WITH THE DEVICE. THERE WAS NO NEEDLE STRIKE MARK ON THE FACE OF THE BARREL TO INDICATE THAT A NEEDLE WAS DEFLECTED. ALTHOUGH, THE SHEATH HAD DISBANDED FROM THE GUIDE THAT WAS CONSISTENT WITH THE REPORTED EXPERIENCE, THERE WAS EVIDENCE THAT THE TWO COMPONENTS WERE PREVIOUSLY BONDED. SHEATH MATERIAL WAS EVIDENT AT THE BOND SITE AND EXHIBITED TORN PORTIONS WHERE THE CRIMP DIMPLE ON THE RING WAS LOCATED. HOWEVER, THE INVESTIGATION WAS UNABLE TO DETERMINE CAUSE FOR THE DISBANDMENT. DETACHMENT OF THE PROSTAR XL SHEATH COULD REQUIRE SURGICAL REMOVAL AND RESULT IN CONTINUED BLEEDING THAT WOULD REQUIRE AN ALTERNATIVE METHOD TO ACHIEVE HEMOSTASIS. THERE WERE NO MANUFACTURING OR QUALITY ISSUES DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT, THEREFORE THE PROBABLE CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE LOT HISTORY RECORD FOR THE REPORTED LOT WAS PERFORMED AND DID NOT REVEAL A NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THE DAILY LOT TESTING FOR THE SHEATH-RING-GUIDE CRIMP JOINT TENSILE STRENGTH WAS CONFIRMED TO BE WITHIN SPECIFICATIONS. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR SHEATH DETACHMENT, FAILURE TO DEPLOY NEEDLES, AND FOR DEPLOYMENT OF THE NEEDLES A SECOND TIME FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO ENDOVASCULAR ANEURYSM REPAIR PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES IN THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROSTAR XL DEVICE. REPORTEDLY, AFTER DEPLOYING A PROGLIDE DEVICE SUCCESSFULLY, AN ATTEMPT WAS MADE TO DEPLOY A PROSTAR XL ALSO. THE DEVICE WAS INSERTED INTO THE VESSEL WITHOUT DIFFICULTY. DURING NEEDLE DEPLOYMENT ONLY THREE OF THE FOUR NEEDLES PRESENTED AT THE HUB OF THE DEVICE. THE NEEDLES WERE BACKED-DOWN, REDEPLOYED A SECOND TIME, AND THE SUTURES WERE HARVESTED. DURING DEVICE REMOVAL, THE GUIDE APPEARED TO BE DETACHED AT THE SHEATH, BUT REMAINED ATTACHED AT THE HOLDER STOP. THE PHYSICIAN DID NOT FEEL COMFORTABLE PULLING THE DEVICE OUT; INSTEAD, A SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE DEVICE AND THE VESSEL WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. IT WAS BELIEVED, BUT NOT CONFIRMED, THAT DURING NEEDLE DEPLOYMENT, A NEEDLE HIT A PLAQUE SHELF CAUSING IT TO DEFLECT. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN WAS REPORTEDLY TRAINED IN THE USE OF THE PROSTAR XL DEVICE. 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 940376H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention PROGLIDE DEVICE (PART#: 12673-03, LOT#: UNK)