BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 22435887 · Received July 8, 2025

    Report

    Report Number
    2024168-2025-06952
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    June 10, 2025
    Report Date
    August 15, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION, FUNCTIONAL TESTING, DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS AND SHEATH/ GUIDE SEPARATION WERE CONFIRMED. THE REPORTED DIFFICULTY CLOSING THE FOOT AND DEVICE ENTRAPMENT COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST 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 REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. TORSIONAL MANIPULATION APPLIED DURING DEVICE PLACEMENT ATTEMPT MAY HAVE CONTRIBUTED TO THE REPORTED SEPARATION OF THE GUIDE AS OBSERVED IN THE RETURNED DEVICE ANALYSIS. SEPARATION OF THE GUIDE CAN COMPROMISE NEEDLE TRAJECTORY THUS CONTRIBUTING TO THE REPORTED NEEDLE TO CUFF MISS SUCH THAT THE FOOT POCKETS/ CUFFS WOULD NO LONGER BE WITH IN THE PATH OF THE NEEDLES. ADDITIONALLY, SEPARATION OF THE GUIDE WOULD COMPROMISE FOOT FUNCTIONALITY WHICH WOULD SUBSEQUENTLY CONTRIBUTE TO THE REPORTED DEVICE ENTRAPMENT. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 5041641 TO 5031442 D4 - EXPIRATION DATE: UPDATED FROM 3/31/2027 TO 2/28/2027 D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 4/16/2025 TO 3/14/2025.

    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 DEVICE REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTICED WITH A PROSTYLE DEVICE. AN ATTEMPT WAS MADE WITH ANOTHER PROSTYLE DEVICE; HOWEVER, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS ALSO NOTICED. WHEN ATTEMPTING TO REMOVE THE PROSTYLE DEVICE FROM THE PATIENT, IT BECAME STUCK. THE PHYSICIAN ROTATED THE DEVICE MANY TIMES, AS WELL AS OPENING AND CLOSING THE LEVER A FEW TIMES TO MAKE SURE THE FOOT OF THE DEVICE HAD CLOSED COMPLETELY, WITHOUT SUCCESS. A VASCULAR SURGEON WAS CALLED IN TO RETRIEVE THE DEVICE, WHOM NOTICED THAT THE PROXIMAL (METAL) GUIDE WAS SEPARATED FROM THE DISTAL BLACK SHEATH PORTION. THE VASCULAR SURGEON PERFORMED A SMALL CUT TO RETRIEVE THE BLACK SHEATH FROM THE PATIENT USING FORCEPS. THE SHEATH WAS UPSIZED TO A 14F AND THE TAVI PROCEDURE WAS COMPLETED. THE ACCESS SITE HOLE WAS SURGICALLY CLOSED AND HEMOSTASIS WAS ACHIEVED. THE PHYSICIAN THAT HAD USED THE PROSTYLE DEVICES STATED THAT THE ARTERIAL WALL WAS TOO THICK AND MANY ROTATIONS AND FORCES WERE APPLIED ON THE PROSTYLE WHEN IT BECAME STUCK WHICH MIGHT HAVE LED TO THE PROXIMAL GUIDE SEPARATING FROM THE BLACK DISTAL SHEATH PORTION OF THE DEVICE. THE PATIENT DIED TWO DAYS POST PROCEDURE, ON (B)(6) 2025, FROM MESENTERIC ISCHEMIA. THE PHYSICIAN CONFIRMED THAT THE PROSTYLE DEVICES HAD FAILED DUE TO THE THICK ARTERIAL WALL OF THE PATIENT AS THEY HAD DIFFICULTIES INTRODUCING THE PROSTYLE INSIDE THE ARTERY. THE PHYSICIAN ALSO CONFIRMED THAT THE PATIENT DEATH WAS NOT DUE TO THE PROSTYLE DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071469 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 5031442 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention