BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 19887605 · Received August 1, 2024

    Report

    Report Number
    2024168-2024-09122
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 13, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE FAILURE TO CYCLE WAS CONFIRMED. THE IRREGULAR APPEARANCE (PULSATILE MARK) IS RELATED TO THE CASE CONDITIONS AND CANNOT BE REPLICATED IN A LAB ENVIRONMENT. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED AND ANALYSIS OF THE RETURNED DEVICE, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS IT IS POSSIBLE THAT THE CALCIFICATION DID NOT ALLOW THE MARKER PORT TO POSITIONED IN THE ACCESS SUFFICIENTLY TO PREVENT ITS EXPOSURE TO PULSATILE BLOOD FLOW. THE CALCIFICATION LIKELY ALSO CONTRIBUTED TO THE CUFF MISS. 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. CORRECTIONS: D4 - LOT #: UPDATED FROM 4031443 TO 4020741. D4 - EXPIRATION DATE: UPDATED FROM 2/28/2026 TO 1/31/2026. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 3/14/2024 TO 2/7/2024.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PROSTYLE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF THE MODERATELY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO AN IMPELLA INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTICED WITH THREE (3) PROSTYLE DEVICES. IT WAS NOTED THAT WHEN THE PROSTYLES WERE INSERTED AND POSITIONED PRIOR TO DEPLOYMENT THAT THERE WAS PULSATILE BLOOD FLOW FROM THE MARKER LUMEN. THE DEVICES WERE PULLED BACK AGAINST THE VESSEL WALL AND THE BLOOD MARKING CEASED; HOWEVER, WHEN THE PUSHING THE NEEDLE PLUNGER TO DEPLOY THE DEVICES THERE WAS BLEEDING FROM THE MARKER LUMEN AGAIN. IT WAS BELIEVED THAT THIS WAS LIKELY CAUSED FROM THE CALCIFICATION. THE SUTURES OF A FOURTH PROSTYLE WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE PHYSICIAN DECIDED TO ABORT THE PRE-CLOSE TECHNIQUE AND PULLED THE PROSTYLE SUTURE OUT. A 14F SHEATH WAS PUT IN AND AS THE IMPELLA REMAINED IN THE PATIENT, CLOSURE OF THE ARTERY WAS NOT COMPLETED. THE 14F SHEATH REMAINED IN THE ARTERY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740389 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 4020741 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention