BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2183060 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05369
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE CONDITION SUBSTANTIATED THE REPORTED EVENT AND REVEALED THAT THE POSTERIOR CUFF MISS OCCURRED DURING THE NEEDLE DEPLOYMENT AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THE POSTERIOR NEEDLE TIP WAS RELEASED FROM THE SHANK, BUT DID NOT ENGAGE WITH THE POSTERIOR CUFF AND REMAINED UNDISTURBED. THIS IS CONSISTENT WITH THE POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM POSTERIOR FOOT DURING NEEDLE DEPLOYMENT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET AS INTENDED. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE AS INDICATED BY THE DAMAGED ANTERIOR CUFF TABS AND ANTERIOR NEEDLE BARB. THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT RESULTED IN THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT INCLUDED, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS AND INCORRECT DEPLOYMENT TECHNIQUES. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING. DURING TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST INCORRECT DEPLOYMENT TECHNIQUE. BASED ON THE SUCCESSFUL TESTING OF THE DEVICE NEEDLE TRAJECTORY, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED AS A RESULT OF THIS INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY 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 ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY WAS ATTEMPTED USING THE PERCLOSE PROGLIDE DEVICE AFTER A PERCUTANEOUS ENDOVASCULAR AORTIC VALVE REPLACEMENT. REPORTEDLY, THE DEVICE FAILED. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 030186H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention