BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 20401025 · Received October 8, 2024

    Report

    Report Number
    2024168-2024-11866
    Event Type
    Death
    Date Received
    October 8, 2024
    Date of Event
    September 10, 2024
    Report Date
    November 5, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. THE PATIENT EFFECT OF DEATH IS LISTED IN THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (IFU), AS POTENTIAL ADVERSE EVENTS OF USE OF THE DEVICE. THIS CASE WAS REVIEWED BY AN ABBOTT MEDICAL REVIEWER. THE REVIEWER CONCLUDED: THIS WAS A CASE TO PRE-CLOSE A COMMON FEMORAL ARTERY OF AN UNREPORTED LATERALITY. THE PATIENT¿S PAST MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT WAS UNDERGOING AN IMPELLA PERCUTANEOUS VENTRICLE ASSIST DEVICE (PVAD) PROCEDURE, WHICH IMPLIES THAT THE PATIENT WAS MOST LIKELY NOT IN A STABLE CONDITION OR HAD MULTIPLE CO-MORBIDITIES THAT REQUIRED ADDITIONAL CARDIAC SUPPORT. TWO (2) PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICES WERE SUCCESSFULLY PRE-PLACED PRIOR TO THE UPSIZING OF THE SHEATH FOR THE IMPELLA PVAD. IT IS UNKNOWN IF THIS WAS THE PATIENT'S ONLY PROCEDURE OR IF THEY HAD ADDITIONAL INTERVENTIONAL PROCEDURES THAT REQUIRED CARDIAC SUPPORT. IT IS UNKNOWN IF THE IMPELLA PVAD WAS REMOVED AT THE END OF THE PROCEDURE. HOWEVER, IT WAS REPORTED THAT POST-PROCEDURE HEMOSTASIS COULD NOT BE ACHIEVED, PRESUMABLY WITH THE PRE-PLACED SUTURES, THOUGH THIS WAS NOT REPORTED. THE TEAM ATTEMPTED TO GET THE PATIENT TO AN OPERATING ROOM, HOWEVER, THE PATIENT EXPIRED BEFORE THEY COULD. WITH THE LIMITED INFORMATION PROVIDED, IT CANNOT BE STATED THAT THE TWO (2) PROGLIDE SMCS DEVICES WERE A DIRECT CAUSE OR CONTRIBUTOR TO THIS PATIENT¿S DEATH. THIS PATIENT APPEARS TO HAVE BEEN IN CRITICAL CONDITION, REQUIRING AN IMPELLA PVAD FOR CARDIAC SUPPORT. IT WAS NOT REPORTED WHAT, IF ANY, ADVERSE EVENTS THE PATIENT EXPERIENCED OR IF THE PATIENT WAS BLEEDING UNCONTROLLABLY, IF ANY ADDITIONAL GROIN MANAGEMENT METHODS WERE ATTEMPTED OR IF THE PATIENT EXPERIENCED ANOTHER ADVERSE EVENT RELATED TO THEIR IMPELLA PROCEDURE OR PAST MEDICAL HISTORY. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED FAILURE TO ACHIEVE HEMOSTASIS COULD NOT BE DETERMINED. FACTORS THAT CONTRIBUTE TO FAILURE TO ACHIEVE HEMOSTASIS, INCLUDE, BUT NOT LIMITED TO, USER TECHNIQUE (POOR OR PARTIAL TISSUE CAPTURE, AIR KNOT). ADDITIONALLY, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4 - A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO AN IMPELLA PROCEDURE. THE SUTURES OF TWO PROGLIDE DEVICES WERE SUCCESSFULLY PLACED. THE SHEATH WAS UPSIZED TO 14F AND THE IMPELLA PROCEDURE WAS COMPLETED. REPORTEDLY POST PROCEDURE, HEMOSTASIS COULD NOT BE ACHIEVED. THE PATIENT DIED BEFORE THEY COULD GET TO THE OPERATION ROOM. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16023 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death CLOSURE DEVICE: PROGLIDE