BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2088252 · Received May 13, 2011

    Report

    Report Number
    2024168-2011-03425
    Event Type
    Injury
    Date Received
    May 13, 2011
    Report Date
    April 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: 0.035 INCH HYDROPHILIC GUIDE WIRE; SHEATH: 9FR VASCULAR SHEATH. OTHER: PROTAMINE , DEXAMETHASONE. OTHER: ENDOGRAFT SHEATH SIZES AND MODELS: 38 ZENITH (COOK), 31 VALIANT (MEDTRONIC), 16 HERCULES (MICROPORT). OUTER DIAMETER OF STENT-GRAFT: 20 FR (19), 22 FR (35), 24 FR (26), 25 FR (5). THE THORACIC AORTIC PROCEDURES WERE PERFORMED BETWEEN (B)(6) 2009 AND (B)(6) 2010. IT SHOULD BE NOTED THAT THE PHYSICIAN BELIEVES THE ADVERSE OUTCOMES FROM THIS STUDY ARE NOT UNCOMMON IN FEMORAL PUNCTURES AND DO NOT THINK THEY WERE RELATED TO THE DEVICE. THE USE OF THE PROGLIDE DEVICES IS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU). THE PERCLOSE PROGLIDE 6F SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 8F SHEATHS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. TOTALLY PERCUTANEOUS THORACIC ENDOVASCULAR AORTIC REPAIR WITH THE PRECLOSING TECHNIQUE: A CASE-CONTROL STUDY. CHINESE MEDICAL JOURNAL 2011: 124(6):851-855.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED DURING A RETROSPECTIVE STUDY LITERATURE REVIEW THAT COMPARED PRE-CLOSING TECHNIQUE USING THE PROGLIDE DEVICE VERSUS SURGICAL FEMORAL CUT DOWN: A TOTAL OF 236 PATIENTS UNDERWENT PERCUTANEOUS THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR); IN 85 PATIENTS, A PRE-CLOSURE TECHNIQUE WAS USED, AND 151 UNDERWENT SURGICAL CUT DOWN. IN THE PRECLOSURE GROUP, THERE WERE 8 EARLY COMPLICATIONS THAT INCLUDED 6 HEMATOMAS AND 2 PSEUDOANEURYSMS. NO BLOOD TRANSFUSION WAS NECESSARY IN ANY OF THESE ADVERSE OUTCOMES. THE 6 HEMATOMAS WERE VERY SMALL AND NOT SERIOUS, THEY WERE TREATED BY MANUAL COMPRESSION. THE 2 PSEUDOANEURYSMS WERE TREATED SURGICALLY. THE PHYSICIANS BELIEVE THOSE ADVERSE OUTCOMES ARE NOT UNCOMMON IN FEMORAL PUNCTURES AND DO NOT THINK THEY WERE RELATED TO THE DEVICE. THE PHYSICIAN INDICATED THAT THE CAUSE OF THE PSEUDOANEURYSMS COULD POSSIBLY BE DUE TO THE PUNCTURE ANGLE. THE ARTICLE INDICATES TECHNICAL SUCCESS WAS ACHIEVED IN ALL CLOSURES. THE DEVICES WERE USED "OFF-LABEL" SINCE VESSEL CLOSURE FOLLOWED 20-25 FR STENT-GRAFTS PLACEMENT. SEVENTY EIGHT ARTERIES REQUIRED TWO DEVICES FOR CLOSURE, 3 DEVICES WERE REQUIRED IN 5 ARTERIES AND 4 DEVICES WERE REQUIRED IN 2 CASES. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention