BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAFLO BYPASS GRAFT

    MDR report key: 17442837 · Received August 2, 2023

    Report

    Report Number
    2020394-2023-00551
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    June 26, 2023
    Report Date
    September 26, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    UDI-DI
    00801741023590
    PMA / PMN Number
    K983861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 08/2027). H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : DEVICE PENDING RETURN.

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE REPORTED MATERIAL PUNCTURE/HOLE ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: B5, D4 (EXPIRY DATE: 08/2027), G3, H6 (METHOD). H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE MONTHS POST A SURGICAL GRAFT PLACEMENT PROCEDURE, GRAFT MATERIAL ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PSEUDOANEURYSM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE MONTHS POST-SURGICAL GRAFT PLACEMENT PROCEDURE, GRAFT MATERIAL ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PSEUDOANEURYSM. FURTHERMORE, ATTEMPT WAS MADE AT ENDOVASCULAR REPAIR OF THE PSEUDOANEURYSM, BUT THE DEFECT APPEARED TO BE TOO PROXIMAL FOR COMFORTABLE COVERAGE WITH A STENT GRAFT. REPORTEDLY, PSEUDOANEURYSM WAS RESECTED AND AS THE ENTIRE GRAFT WAS EXTREMELY WELL INCORPORATED, SO INTERPOSITION WAS PERFORMED USING A FUSION BIOLINE GRAFT TO THE DISTAFLOW, AND THE GRAFT-GRAFT ANASTOMOSIS STENTED WITH A COVERED STENT GRAFT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797111 DISTAFLO BYPASS GRAFT EPTFE VASCULAR GRAFT DSY BARD PERIPHERAL VASCULAR, INC. VTGV0257 00801741023590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention