BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOFLO EPTFE VASCULAR GRAFT

    MDR report key: 6059392 · Received October 26, 2016

    Report

    Report Number
    2020394-2016-01006
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 30, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DYF
    UDI-DI
    00801741021626
    PMA / PMN Number
    K004012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. VISUAL INSPECTION & FUNCTIONAL/PERFORMANCE EVALUATION: THE DEVICE WAS NOT RETURNED; THEREFORE, NO VISUAL INSPECTION OR FUNCTIONAL TESTING OF THE DEVICE WAS PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED FOR REVIEW. CONCLUSION: THE INVESTIGATION WAS INCONCLUSIVE FOR TORN MATERIAL, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT WAS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT INSTRUCTION FOR USE (IFU) STATES: EPTFE GRAFTS DO NOT STRETCH (ARE NON-ELASTIC) IN THE LONGITUDINAL DIRECTION. THE CORRECT GRAFT LENGTH FOR EACH PROCEDURE MUST BE DETERMINED BY CONSIDERING THE PATIENT'S BODY WEIGHT, POSTURE, AND THE RANGE OF MOTIONS ACROSS THE ANATOMICAL AREA OF GRAFT IMPLANTATION. FAILURE TO CUT THE GRAFT TO AN APPROPRIATE LENGTH MAY RESULT IN ANASTOMOTIC OR GRAFT DISRUPTION, LEADING TO EXCESSIVE BLEEDING, AND LOSS OF LIMB OR LIMB FUNCTION, AND/OR DEATH. AGGRESSIVE AND/OR EXCESSIVE GRAFT MANIPULATION WHEN TUNNELING, OR PLACEMENT WITHIN A TOO TIGHT OR TOO SMALL TUNNEL, MAY LEAD TO SEPARATION OF THE SPIRAL BEADING AND/OR GRAFT BREAKAGE. WHEN SUTURING, AVOID EXCESSIVE TENSION ON THE SUTURE LINE, INAPPROPRIATE SUTURE SPACING AND BITES, AND GAPS BETWEEN THE GRAFT AND HOST VESSEL. FAILURE TO FOLLOW CORRECT SUTURING TECHNIQUES MAY RESULT IN SUTURE HOLE ELONGATION, SUTURE PULL-OUT, ANASTOMOTIC BLEEDING AND/OR DISRUPTION. ADDITIONAL MFR NARRATIVE: DATE RECEIVED BY MFR; (CONCLUSION); THE INFORMATION PROVIDED BY BARD 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 BARD.

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF THE VASCULAR GRAFT AN ALLEGED SPLIT WAS IDENTIFIED APPROXIMATELY ¾ OF THE WAY DOWN FROM THE SUTURE SITE; THEREFORE, THE TORN SECTION OF THE GRAFT WAS CUT AND REMOVED. IT WAS FURTHER REPORTED THAT THE REMAINDER OF THE GRAFT WAS RE SUTURED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF THE VASCULAR GRAFT AN ALLEGED SPLIT WAS IDENTIFIED APPROXIMATELY 3/4 OF THE WAY DOWN FROM THE SUTURE SITE; THEREFORE, THE TORN SECTION OF THE GRAFT WAS CUT AND REMOVED. IT WAS FURTHER REPORTED THAT THE REMAINDER OF THE GRAFT WAS RE SUTURED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708548 CARBOFLO EPTFE VASCULAR GRAFT EPTFE VASCULAR GRAFT DYF BARD PERIPHERAL VASCULAR, INC. VTZK0436 00801741021626

    Patients

    Seq Age Sex Outcome Treatment
    1