BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAFLO BYPASS GRAFT

    MDR report key: 1328888 · Received February 27, 2009

    Report

    Report Number
    2020394-2009-00057
    Event Type
    Injury
    Date Received
    February 27, 2009
    Date of Event
    January 15, 2009
    Report Date
    February 5, 2009
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DYF
    PMA / PMN Number
    K983861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE SAMPLE WAS NOT EVALUATED AS IT REMAINS IMPLANTED IN THE PT. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER TO DATE. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: "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. ADVERSE REACTIONS: POTENTIAL COMPLICATIONS WHICH MAY OCCUR WITH ANY SURGICAL PROCEDURE INVOLVING A VASCULAR PROSTHESIS INCLUDE, BUT ARE NOT LIMITED TO: DISRUPTION OR TEARING OF THE SUTURE LINE, GRAFT, AND/OR HOST VESSEL; SUTURE HOLE BLEEDING: GRAFT REDUNDANCY; THROMBOSIS, EMBOLIC EVENTS, OCCLUSION OR STENOSIS; ULTRAFILTRATION; SEROMA FORMATION; SWELLING OF THE IMPLANTED LIMB; FORMATION OF HEMATOMA OR PSEUDOANEURYSM; INFECTION; ANEURYSM/DILATION; BLOOD LEAKAGE; HEMORRHAGE; STEAL SYNDROME; AND/OR SKIN EROSION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY AFTER A FEMORAL TO POPLITEAL SHUNT PROCEDURE WAS PERFORMED, A TEAR IN THE CUFF A FEW MILLIMETERS IN LENGTH WAS OBSERVED. THE PHYSICIAN UTILIZED END-TO-SIDE ANASTOMOSES. THE BLEEDING WAS NOT OBSERVED UNTIL AFTER BLOOD FLOW WAS REESTABLISHED AND THE SKIN WAS SUTURED. WHEN THE OPERATION WAS ABOUT TO BE COMPLETED, THE PT'S BLOOD PRESSURE SUDDENLY DROPPED. THE SURGERY SITE WAS REOPENED AND BLEEDING WAS OBSERVED ORIGINATING FROM THE ANASTOMOSIS BETWEEN COMMON FEMORAL ARTERY AND THE CUFF IN THE GRAFT WHERE THE CUFF HAD RIPPED BY A FEW MILLIMETERS IN LENGTH. THE SITE WAS TRIMMED AND THE CUFF WAS RE-SUTURED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAFLO BYPASS GRAFT DYF BARD PERIPHERAL VASCULAR, INC. 5986604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention