BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPRA CARBOFLO TAPERED EPTFE GRAFT

    MDR report key: 5054939 · Received September 3, 2015

    Report

    Report Number
    2020394-2015-01578
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 6, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DYF
    PMA / PMN Number
    K004012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA. VISUAL/MICROSCOPIC INSPECTION AND FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS NOT RETURNED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED. IMAGE/PHOTO REVIEW: NO IMAGES OR PHOTOS WERE PROVIDED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED GRAFT TEAR. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. LABELING/REVIEW: IMPRA 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. 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 ALLEGEDLY TWO DAYS POST PROCEDURE THE PATIENT HAD A SEVERE BLEEDING WITH A GRAFT RUPTURE OF THREE CENTIMETERS BEFORE THE DISTAL ANASTOMOSIS OF AN AV FISTULA. REPORTEDLY, THE PATIENT UNDERWENT MEDICAL INTERVENTION FOR THE GRAFT REMOVAL. A SEVERE WOUND INFECTION WAS DEVELOPED AND THE PATIENT REMAINS IN THE HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585358 IMPRA CARBOFLO TAPERED EPTFE GRAFT EPTFE GRAFT DYF BARD PERIPHERAL VASCULAR, INC. VTYH0642

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention