BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3044688 · Received April 9, 2013

    Report

    Report Number
    2024168-2013-02140
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    May 2, 2012
    Report Date
    March 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    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 DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DATE OF EVENT AND THERAPY ESTIMATED AS DATE OF PUBLICATION, 05/02/2012. ATTACHMENT: PHILIPP KAHLERT, MD; FADI AL-RASHID, MD; BJO RN PLICHT, MD; THOMAS KONORZA, MD; TILL NEUMANN, MD; MATTHIAS THIELMANN, MD, FAHA; DANIEL WENDT, MD; RAIMUND ERBEL,MD, FESC, FAHA, FACC, FASE; AND HOLGER EGGEBRECHT, MD, FESC, FACC. (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2013; 81:E139E150): SUTURE-MEDIATED ARTERIAL ACCESS SITE CLOSURE AFTER TRANSFEMORAL AORTIC VALVE IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS INFORMATION WAS CAPTURED BASED ON LITERATURE REVIEW: A RETROSPECTIVE ANALYSIS WAS PERFORMED TO EVALUATE FEASIBILITY, SAFETY, AND EFFICACY OF PERCUTANEOUS ARTERIAL ACCESS SITE CLOSURE AFTER TRANSFEMORAL, TRANSCATHETER AORTIC VALVE IMPLANTATION (TF-TAVI) USING A SINGLE, COMMERCIALLY AVAILABLE SIX FRENCH MONOFILAMENT SUTURE-MEDIATED VASCULAR CLOSURE DEVICE (VCD) IN PRECLOSURE- TECHNIQUE. PATIENT NUMBER: 135. DESCRIPTION OF EVENT: HIGH-GRADE STENOSIS/SUBTOTAL OCCLUSION OF THE COMMON FEMORAL ARTERY. STENOSIS ON QUANTITATIVE VESSEL ANALYSIS: 96%. DURATION OF FOLLOW-UP (MONTHS): 13. TREATMENT /OUTCOME: VASCULAR SURGERY (RECOVERED WITHOUT SEQUELAE). NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147753 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATHS: 8-FRENCH, 10-FRENCH, 18-FRENCH HEPARIN