BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 18448862 · Received January 4, 2024

    Report

    Report Number
    2024168-2024-00199
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    December 13, 2023
    Report Date
    August 14, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    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 PERCLOSE PROSTYLE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED TO THE RETURNED DEVICE. THE REPORTED SUTURE RETRIEVAL ISSUE WAS OBSERVED AS A LINK SEPARATION. PRODUCTION RECORDS AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THAT THE REPORTED SUTURE RETRIEVAL ISSUE AND UNEXPECTED MEDICAL INTERVENTION APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. IT IS LIKELY THAT AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR LINK PULLED UNTIL IT BREAKS DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D1 CORRECTION: BRAND NAME UPDATED. D2A CORRECTION: COMMON DEVICE NAME UPDATED. D3 CORRECTION: NAME, ADDRESS UPDATED. D9, H3 CORRECTION: DEVICE RETURNING UPDATED FROM NI TO YES . E1 CORRECTION: HOSPITAL NAME: UPDATED FROM ANADIAN HOSPITAL SPECIALTIES LTD TO (B)(6) HOSPITAL. H6 CORRECTION: TYPE OF INVESTIGATION CODE 4114 REMOVED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VESSEL CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED USING SEVEN PROSTYLE DEVICES. REPORTEDLY, ALL SEVEN DEVICES FAILED TO DEPLOY. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT SUTURE PLACEMENT IN THE CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH FOUR PROSTYLE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED WITH ALL FOUR PROSTYLE DEVICES. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO AN 18F AND THE AAA PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED:IT WAS REPORTED THAT SUTURE PLACEMENT IN THE CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH FOUR PROSTYLE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED WITH ALL FOUR PROSTYLE DEVICES. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO AN 18F AND THE AAA PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574781 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 3040442 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention