BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAFLO BYPASS GRAFT

    MDR report key: 7162810 · Received January 3, 2018

    Report

    Report Number
    2020394-2017-01864
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    November 8, 2016
    Report Date
    March 2, 2018
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    PMA / PMN Number
    K983861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO HOSPITAL/MEDICAL RECORDS HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. ARTICLE REVIEW: A SURGICAL BYPASS GRAFT WAS IMPLANTED IN A DIABETIC PATIENT WITH A HISTORY OF LEFT CRITICAL LIMB ISCHEMIA AND NECROTIC FOOT ULCERS WITH PRIOR OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY SEGMENT. THE PATIENT HAD A LEFT EXTERNAL ILIAC TO ABOVE KNEE POPLITEAL BYPASS WITH A POLYTETRAFLUOROETHYLENE GRAFT ALONG WITH FIRST AND SECOND TOE AMPUTATION. AS A RESULT OF THE OCCLUSION, BALLOON ANGIOPLASTY WAS PERFORMED. COMPLETION ANGIOGRAPHY DEMONSTRATED FULL REVASCULARIZATION OF THE SUPERFICIAL FEMORAL ARTERY WITH RAPID FLOW INTO THE BELOW KNEE VESSELS. HUSAINY, M.A., SLIM, H., RASHID, H., HUANG, D.Y. (2017). RECANALISATION OF CHRONICALLY OCCLUDED REMOTE SUPERFICIAL FEMORAL ARTERY ENDARTERECTOMY THROUGH ANGIOPLASTY FOR LIMB SALVAGE. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 40, 302-305. DOI: 10.1007/S00270-016-1499-7. 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

    MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. ARTICLE REVIEW: A SURGICAL BYPASS GRAFT WAS IMPLANTED IN A DIABETIC PATIENT WITH A HISTORY OF LEFT CRITICAL LIMB ISCHEMIA AND NECROTIC FOOT ULCERS WITH PRIOR OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY SEGMENT. THE PATIENT HAD A LEFT EXTERNAL ILIAC TO ABOVE KNEE POPLITEAL BYPASS WITH A POLYTETRAFLUOROETHYLENE GRAFT ALONG WITH FIRST AND SECOND TOE AMPUTATION. AS A RESULT OF THE OCCLUSION, BALLOON ANGIOPLASTY WAS PERFORMED. COMPLETION ANGIOGRAPHY DEMONSTRATED FULL REVASCULARIZATION OF THE SUPERFICIAL FEMORAL ARTERY WITH RAPID FLOW INTO THE BELOW KNEE VESSELS. HUSAINY, M.A., SLIM, H., RASHID, H., HUANG, D.Y. (2017). RECANALISATION OF CHRONICALLY OCCLUDED REMOTE SUPERFICIAL FEMORAL ARTERY ENDARTERECTOMY THROUGH ANGIOPLASTY FOR LIMB SALVAGE. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 40, 302-305. DOI: 10.1007/S00270-016-1499-7. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, AN IMAGE WAS PROVIDED FOR REVIEW. IMAGING COULD IDENTIFY SIX RADIOPAQUE DENSITIES OF ARTERIAL FLOW IN THE RIGHT LEG AND APPROXIMATELY FOUR RADIOPAQUE DENSITIES OF ARTERIAL FLOW ON THE LEFT LEG. THE ALLEGED IMPLANTED GRAFT COULD NOT BE IDENTIFIED BASED ON THE PROVIDED IMAGE. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED OCCLUSION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: 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 IN AN ARTICLE IN CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY TITLED "RECANALISATION OF CHRONICALLY OCCLUDED REMOTE SUPERFICIAL FEMORAL ARTERY ENDARTERECTOMY THROUGH ANGIOPLASTY FOR LIMB SALVAGE", FOLLOWING GRAFT INPLANTATION, THE EPTFE GRAFT OCCLUDED POST FOUR MONTHS IMPLANT. BALLOON ANGIOPLASTY WAS PERFORMED AND FULL REVASCULARIZATION WITH RAPID FLOW WAS ACHIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY TITLED "RECANALISATION OF CHRONICALLY OCCLUDED REMOTE SUPERFICIAL FEMORAL ARTERY ENDARTERECTOMY THROUGH ANGIOPLASTY FOR LIMB SALVAGE", FOLLOWING GRAFT IMPLANTATION, THE EPTFE GRAFT OCCLUDED POST FOUR MONTHS INPLANT. BALLOON ANGIOPLASTY WAS PERFORMED AND FULL REVASCULARIZATION WITH RAPID FLOW WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5764 DISTAFLO BYPASS GRAFT VASCULAR GRAFT DSY BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention