BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAFLO BYPASS GRAFT

    MDR report key: 1033815 · Received April 24, 2008

    Report

    Report Number
    2020394-2008-00101
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    PMA / PMN Number
    K983861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE SERIAL # WAS UNK. THE SAMPLE WAS APPROX 3 CM IN LENGTH AND CONSISTED OF BOTH TISSUE AND 2 GRAFT FRAGMENTS. THE GRAFT FRAGMENTS MEASURING APPROX 1.0 CM AND 1.5 CM ARE STILL ATTACHED/EMBEDDED INTO THE CONNECTING TISSUE. THE REMAINDER OF THE GRAFT WAS NOT RETURNED. THE GRAFT SEGMENT HAD BEEN DISSECTED LEAVING ALL EDGES APPEARING CLEAN CUT. BECAUSE OF THE SAMPLE CONDITION, IT IS NOT POSSIBLE TO DETERMINE WHERE THE BREAK OCCURRED. THE CURRENT IFU STATES: ANASTOMOTIC OR GRAFT DISRUPTION HAS BEEN ASSOCIATED WITH AXILLOFEMORAL, FEMORAL FEMORAL, OR AXILLOBIFEMORAL BYPASS PROCEDURES IF IMPLANTED IMPROPERLY. REFER TO SPECIFIC OPERATIVE PROCEDURES (EXTRA-ANATOMIC BYPASS PROCEDURES) FOR FURTHER INSTRUCTIONS. FOR EXTRA ANATOMIC PROCEDURES (E.G. AXILLOFEMORAL, FEMORAL FEMORAL, OR AXILLOBIFEMORAL BYPASS), THE PT SHOULD BE CAUTIONED THAT SUDDEN, EXTREME OR STRENUOUS MOVEMENTS SHOULD BE TOTALLY AVOIDED FOR A PERIOD OF AT LEAST SIX TO EIGHT WEEKS TO ALLOW FOR PROPER STABILIZATION OF THE GRAFT. ROUTINE ACTIVITIES SUCH AS RAISING THE ARMS ABOVE THE SHOULDERS, REACHING OUT IN FRONT, EXTENDED REACHING, THROWING, PULLING, STRIDING, OR TWISTING SHOULD BE AVOIDED. DISTAFLO BYPASS GRAFTS DO NOT STRETCH (ARE NON-ELASTIC) IN THE LONGITUDINAL DIRECTION. THE CORRECT GRAFT LENGTH FOR EACH PROCEDURE MUST BE DETERMINED BY CONSIDERING THE PT'S BODY WEIGHT, POSTURE, AND THE RANGE OF MOTIONS ACROSS THE ANATOMICAL AREA OF THE 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 THIGH OR TOO SMALL TUNNEL, MAY LEAD TO SEPARATION OF THE SPIRAL BEADING AND/OR GRAFT BREAKAGE. THE DISTAL ANASTOMOSIS SHOULD BE MADE AFTER TUNNELING OR SUTURE DISRUPTION CAN OCCUR. DO NO PASS THE CUFF PORTION (DISTAL END) OF THE DISTAFLO BYPASS GRAFT THROUGH A TUNNELER SHEATH OR THE TISSUE TUNNEL, AS THIS COULD LEAD TO SEPARATION OF THE SPIRAL BEADING AND/OR GRAFT BREAKAGE. FOR EXTRA-ANATOMIC BYPASS PROCEDURES, CAREFUL ATTN MUST BE GIVEN TO THE FOLLOWING TECHNIQUES. FAILURE TO FOLLOW THESE TECHNICAL CONSIDERATIONS MAY RESULT IN SUTURE HOLE ELONGATION, MECHANICAL DISRUPTION, OR TEARING OF THE GRAFT, SUTURE LINE OR HOST VESSEL, THROMBOSIS, EXTREME BLOOD LOSS, LOSS OF LIB FUNCTION, LOSS OF LIMB OR DEATH. TO AVOID EXTREME STRESS ON THE ANASTAMOSIS AND THE GRAFT, INCLUDE THE PT'S WEIGHT AND RANGE OF LIMB MOTION WHEN DETERMINING THE GRAFT LENGTH, TUNNEL LENGTH AND LOCATION. TO DETERMINE THE CORRECT GRAFT LENGTH, DRAPE THE PT TO ALLOW FULL MOVEMENT OF THE ARM, SHOULDER GIRDLE, OR LEGS. AVOID PROTRACTED HYPER ABDUCTION OF THE ARM DURING THE SURGICAL PROCEDURE. PROLONGED HYPERABDUCTION MAY LEAD TO BRACHIAL PLEXUS INJURY. ALLOW SUFFICIENT GRAFT LENGTH TO AVOID STRESSING OF AXILLARY OR FEMORAL ANASTOMOSIS THROUGHOUT THE FULL RANGE OF MOVEMENT OF THE ARM, SHOULDER GIRDLE, OR LEGS. THE GRAFT SHOULD BE PLACED UNDER BOTH THE PECTORALIS MAJOR AND PECTORALIS MINOR. CUTTING THE GRAFT SLIGHTLY LONGER THAN NECESSARY HAS BEEN REPORTED BY SOME SURGEONS TO FURTHER REDUCE THE RISK OF STRESSING THE GRAFT OR THE ANASTOMOSIS. CORRECTLY BEVEL THE AXILLARY ANASTOMOSIS. STRESS ON THE GRAFT IS MINIMIZED WHEN THE GRAFT IS PLACED PERPENDICULAR (0 DEGREES) TO THE AXILLARY ARTERY. THEREFORE, THE ANASTOMOTIC ANGLE SHOULD BE AS SMALL AS POSSIBLE AND SHOULD NOT EXCEED 25 DEGREES RELATIVE TO THE CUT EDGE OF THE GRAFT. PLACE THE GRAFT ANASTOMOSIS CLOSE TO THE RIB CAGE ON THE FIRST PORTION OF THE AXILLARY ARTERY. DO NOT PLACE THE ANASTAMOSIS ON THE THIRD PORTION OF THE AXILLARY ARTERY. NOTIFY THE PT THAT SUDDEN, EXTREME OR STRENUOUS MOVEMENTS OF THE ARM, SHOULDER OR LEG SHOULD BE TOTALLY AVOIDED FOR A PERIOD OF AT LEAST SIX TO EIGHT WEEKS TO ALLOW FOR PROPER STABILIZATION OF THE GRAFT. ROUTINE ACTIVITIES SUCH AS RAISING THE ARMS ABOVE THE SHOULDERS, REACHING OUT IN FRONT, EXTENDED REACHING, THROWING, PULLING, STRIDING OR TWISTING SHOULD BE AVOIDED. 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 HEMATOMAS OR PSEUDOANEURYSM; INFECTION; SKIN EROSION; ANEURYSM/DILATION; BLOOD LEAKAGE; AND HEMORRHAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFT HAD BEEN PLACED IN FEM-POP BYPASS FOR APPROX ONE AND A HALF YRS. THE PT REPORTED PAIN. FRACTURE OF GRAFT SHAFT WAS FOUND AND REMOVED WITH SURGERY. NO RIGID TISSUE WAS FOUND. TUNNELER WAS USED IN PLACING THE GRAFT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention