BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 5946013 · Received September 13, 2016

    Report

    Report Number
    2020394-2016-00868
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 15, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS LOT NUMBERS WERE NOT PROVIDED. VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICES WERE NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICES WERE NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. JOURNAL ARTICLE REVIEW: THE ARTICLE FOR THE CLINICAL STUDY PRESENTED A FINAL 2-YEAR DATA FROM RANDOMIZED COMPARISON OF A STENT GRAFT AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR TREATMENT OF ARTERIOVENOUS GRAFT (AVG) ANASTOMOTIC STENOSES. CLINICAL STUDY OF 270 PATIENTS, 138 PATIENTS WITH A STENT GRAFT AND 132 PATIENTS WITH PTA ANGIOPLASTY. DURING THE 2-YEAR CLINICAL STUDY, 57 OF THE 132 PTA PATIENTS IN ADDITION TO THE PTA FOR PATIENT STENOTIC VENOUS ANASTOMOSIS, THE PATIENTS NEEDED STENT GRAFTS DEPLOYED DURING THE COURSE OF THROMBOTIC OCCLUSION REVISIONS. THE STENT GRAFT USE PROVIDED A SUSTAINED, GREATER THAN 2-FOLD ADVANTAGE OVER PTA BALLOON ANGIOPLASTY IN TREATMENT AREA AND OVERALL ACCESS PATENCY. OVER THE TWO YEAR CLINICAL STUDY MOST OF THE PATIENTS EXPERIENCED SOME ANASTOMOTIC STENOSIS; SOME PATIENTS EXPERIENCED THROMBOTIC OCCLUSION, REQUIRING PERCUTANEOUS INTERVENTION. HASKAL, Z. J., SAAD, T. F., HOGGARD, J. G., COOPER, R. I., LIPKOWITZ, G. S., GERGES, A., . . . MIETLING, S. W. (2016, AUGUST). PROSPECTIVE, RANDOMIZED, CONCURRENTLY-CONTROLLED STUDY OF A STENT GRAFT VERSUS BALLOON ANGIOPLASTY FOR TREATMENT OF ARTERIOVENOUS ACCESS GRAFT STENOSIS: 2-YEAR RESULTS OF THE RENOVA STUDY. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 27(8), 1105-1114. IMAGE/PHOTO REVIEW: NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: PRECAUTIONS: CAREFUL ATTENTION SHOULD BE PAID TO ENSURE THE DEVICE IS APPROPRIATELY SIZED TO THE ACTUAL GRAFT DIAMETER, TAKING INTO ACCOUNT ANY CHANGE TO THE STATED GRAFT DIAMETER THAT MAY HAVE RESULTED FROM PREVIOUS INTERVENTIONS. THE APPROPRIATE LENGTH DEVICE(S) SHOULD BE SELECTED SO THAT THE STENT GRAFT EXTENDS BEYOND THE STENOSIS INTO AT LEAST 10 MM OF THE NON-DISEASED GRAFT TOWARDS THE ARTERIAL INFLOW AND INTO THE NON-DISEASED VEIN APPROXIMATELY 10 MM BEYOND THE STENOSIS. SERIOUS COMPLICATIONS, SUCH AS MIGRATION TO THE HEART OR LUNGS, HAVE BEEN REPORTED WHEN STENT GRAFTS HAVE NOT BEEN APPROPRIATELY SIZED OR WHEN THE APPROPRIATE LENGTH OF PLACEMENT OF THE PROXIMAL (INFLOW) END OF THE DEVICE (~10 MM) IN THE AV GRAFT IS NOT ACHIEVED. PLEASE NOTE THAT DEVICE MIGRATION MAY OCCUR POST-DISCHARGE AND HAS BEEN REPORTED 3-10 DAYS POST-PROCEDURE. POTENTIAL COMPLICATIONS AND ADVERSE EVENTS: STENT GRAFT SPECIFIC EVENTS THAT COULD BE ASSOCIATED WITH CLINICAL COMPLICATIONS INCLUDE STENT GRAFT MISPLACEMENT, STENT GRAFT MIGRATION, STENT GRAFT FRACTURE, STENT GRAFT KINKING, INSUFFICIENT STENT GRAFT EXPANSION AND STENT GRAFT EMBOLISM. (B)(4). 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 A TWO YEAR CLINICAL STUDY FOR STENT GRAFT VERSUS PTA BALLOON ANGIOPLASTY, FOR TREATMENT OF ARTERIOVENOUS ACCESS GRAFT STENOSIS WAS PERFORMED. ONLY PATIENTS WITH SIGNIFICANT STENOSIS GREATER THAN 50% WITH CLINICAL EVIDENCE OF GRAFT DYSFUNCTION (WITHOUT THROMBOTIC OCCLUSION) WERE ELIGIBLE TO PARTICIPATE IN THE TRIAL. THE CLINICAL TRIAL CONCLUSION WAS: THE STENT GRAFT USE PROVIDED A SUSTAINED, GREATER THAN 2-FOLD ADVANTAGE OVER PTA BALLOON ANGIOPLASTY IN TREATMENT AREA AND OVERALL ACCESS PATENCY. OVER THE TWO YEAR CLINICAL STUDY MOST OF THE PATIENTS EXPERIENCED SOME ANASTOMOTIC STENOSIS; SOME PATIENTS EXPERIENCED THROMBOTIC OCCLUSION, REQUIRING PERCUTANEOUS INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599655 FLAIR ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN, WARFARIN, ASPIRIN