BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 6183316 · Received December 16, 2016

    Report

    Report Number
    2024168-2016-08987
    Event Type
    Death
    Date Received
    December 16, 2016
    Date of Event
    October 1, 2016
    Report Date
    December 16, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO ACHIEVE HEMOSTASIS COULD NOT BE DETERMINED. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF STROKE, DEATH, MYOCARDIAL INFARCTION, AND ACUTE KIDNEY INJURY, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED). THE REPORTED PATIENT EFFECTS OF DISSECTION, DEATH, PSEUDOANEURYSM, HEMORRHAGE AND OCCLUSION ARE A KNOWN INHERENT RISK OF THE PROCEDURE AND THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW 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 A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. USE OF AN EPTFE-COVERED NITINOL SELF-EXPANDING STENT GRAFT FOR THE TREATMENT OFF PRE-CLOSURE DEVICE FAILURE DURING TRANSCATHETER AORTIC VALVE REPLACEMENT.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT A SINGLE-CENTER RETROSPECTIVE STUDY IDENTIFIED A TOTAL OF 25 CONSECUTIVE PATIENTS WITH FAILURE OF VESSEL CLOSURE DEVICES, PROGLIDE AND PROSTAR XL, AFTER TAVR PROCEDURES WHO WERE TREATED WITH STENT-GRAFTS TO ACHIEVE HEMOSTASIS. THE STUDY IDENTIFIED 25 AORTIC STENOSIS PATIENTS BETWEEN JANUARY 2013 AND DECEMBER 2015. CLINICAL OUTCOMES FROM THE USE OF THE CLOSURE DEVICES WERE AS FOLLOWS: OVERT BLEEDING 19 PATIENTS; DISSECTION/NO FLOW 5 PATIENTS; LARGE PSEUDOANEURYSM 1 PATIENT; BLOOD TRANSFUSIONS 15 PATIENTS; ACUTE KIDNEY INJURY (NOT NEEDING DIALYSIS) 4 PATIENTS; POST PROCEDURAL MYOCARDIAL INFARCTION 2 PATIENTS; POST PROCEDURAL STROKE 1 PATIENT; INCOMPLETE VASCULAR ACCESS CLOSURE; MAJOR VASCULAR COMPLICATIONS IN HOSPITAL MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834345 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SHEATH: 8F, 14F, 20F