BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 8805164 · Received July 18, 2019

    Report

    Report Number
    2024168-2019-10161
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 26, 2019
    Report Date
    July 20, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ESTIMATE DATE OF EVENT. THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ARTICLE: THE USE OF CLOSURE DEVICES FOR AORTIC STENT-GRAFT INSERTION: OUTCOMES FOLLOWING A PARADIGM SHIFT TO PERCUTANEOUS ACCESS IN A TERTIARY VASCULAR CENTERNA. ATTACHMENT: [LITERATURE E-000696.PDF].

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2019001. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. IN THE ABSENCE OF DEVICE RETURNED FOR ANALYSIS A CONCLUSIVE CAUSE FOR THE REPORTED SUTURE DETACHMENT AND FAILURE TO ACHIEVE HEMOSTASIS COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF HEMATOMA, EMBOLISM, ISCHEMIA AND SURGERY (SURGICAL EXPOSURE) ARE A KNOWN INHERENT RISK OF THE PROCEDURE AND THE TREATMENTS APPEAR TO BE RELATED TO PROCEDURE CIRCUMSTANCE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    B3: ESTIMATE DATE OF EVENT G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. THE DEVICE(S) IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.NA

    Description of Event or Problem · 0

    DETAILS ARE LISTED IN THE ATTACHED ARTICLE: THE USE OF CLOSURE DEVICES FOR AORTIC STENT-GRAFT INSERTION: OUTCOMES FOLLOWING A PARADIGM SHIFT TO PERCUTANEOUS ACCESS IN A TERTIARY VASCULAR CENTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING PROGLIDE DEVICES THAT MAY BE RELATED TO THE FOLLOWING: FAILURE TO ACHIEVE HEMOSTASIS AND SUTURE BREAK WHICH SURGICAL CUT DOWN AND CLOSURE WERE REQUIRED, LOWER LIMB EMBOLIZATION REQUIRING THROMBECTOMY, HEMATOMA, LOWER LEG ISCHEMIA, SUTURE BREAK. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE: THE USE OF CLOSURE DEVICES FOR AORTIC STENT-GRAFT INSERTION: OUTCOMES FOLLOWING A PARADIGM SHIFT TO PERCUTANEOUS ACCESS IN A TERTIARY VASCULAR CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599059 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-05 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention