BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 6143150 · Received December 2, 2016

    Report

    Report Number
    2020394-2016-01134
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    04049519008837
    PMA / PMN Number
    P060002/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE SUBASSEMBLIES, MATERIAL REVIEW REPORTS, RAW MATERIAL TESTING, MANUFACTURING PROCESS, AND QUALITY CONTROL INSPECTION. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. VISUAL/ MICROSCOPIC INSPECTION: THE DELIVERY SYSTEM WAS RETURNED. THE SAFETY CLIP WAS MISSING UPON RECEIPT OF THE SAMPLE. THE TUOHY BORST ADAPTER WAS LOOSE AND THE TWO-WAY STOP COCK WAS OPENED. IT WAS NOTED THAT THE TUOHY BORST WAS PINNED ALL THE WAY TO THE HANDLE. THE CATHETER WAS BENT 169CM FROM THE STRAIN RELIEF. THE STENT GRAFT WAS FOUND TO BE RELEASED AND WAS NOT RETURNED WITH THE DELIVERY SYSTEM. . A PORTION OF THE INNER CATHETER INCLUDING THE ATRAUMATIC TIP WAS TORN OFF FROM THE DELIVERY SYSTEM AND NOT RETURNED. THE INNER CATHETER IS EXPOSED 22MM FROM THE DISTAL END OF THE CATHETER. NO OTHER ANOMALIES WERE NOTED TO THE RETURNED DELIVERY SYSTEM. FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS RETURNED; HOWEVER, FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED BASED ON THE CONDITION OF THE SAMPLE. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION WAS CONFIRMED FOR DETACHMENT, AS A PORTION OF THE INNER CATHETER INCLUDING THE ATRAUMATIC TIP WAS NOT RETURNED WITH THE REST OF THE DELIVERY SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT WAS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: STENT GRAFT SIZE SELECTION: SPECIAL CARE MUST BE TAKEN TO ENSURE THAT THE APPROPRIATE SIZE FLAIR ENDOVASCULAR STENT GRAFT IS SELECTED. THE STENT GRAFT BODY DIAMETER SHOULD BE APPROXIMATELY 1 MM LARGER THAN THE SYNTHETIC AV ACCESS GRAFT DIAMETER. THE DISTAL END OF THE FLARED CONFIGURATION DEVICES ARE APPROXIMATELY 4 MM LARGER IN DIAMETER THAN THE BODY SECTION. PRECAUTIONS: FAULTY PLACEMENT TECHNIQUES MAY LEAD TO FAILURE IN STENT GRAFT DEPLOYMENT. DO NOT KINK THE DELIVERY SYSTEM. THE DELIVERY SYSTEM CAN FUNCTION ONLY AFTER THE RED SAFETY CLIP HAS BEEN PULLED OFF AND THE TUOHY-BORST VALVE IS LOOSENED. THIS SHOULD NOT BE DONE UNTIL THE STENT GRAFT IS POSITIONED ACROSS THE LESION AND IS READY TO BE DEPLOYED. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE HAVE NOT BEEN ESTABLISHED WHEN USED AROUND A TIGHT BEND IN A LOOPED AV GRAFT. IT IS RECOMMENDED TO ACCESS THE AV GRAFT AT THE VENOUS SIDE OF THE AV GRAFT OR AT THE APEX. POTENTIAL COMPLICATIONS AND ADVERSE EVENTS: DELIVERY SYSTEM SPECIFIC EVENTS THAT COULD BE ASSOCIATED WITH CLINICAL COMPLICATIONS INCLUDE BOND JOINT FAILURES, DETACHMENT OF PARTS, INCOMPATIBILITY WITH ACCESSORY DEVICES, PREMATURE DEPLOYMENT, INACCURATE DEPLOYMENT, FAILURE TO DEPLOY, HIGH DEPLOYMENT FORCES, DELIVERY SYSTEM KINKING, NO VISIBILITY UNDER FLUOROSCOPY, INABILITY TO TRACK TO TARGET LOCATION, AND BLOOD LEAKAGE FROM DELIVERY SYSTEM (HEMOSTASIS). (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.

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE RETURN OF THE DEVICE IS PENDING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT, THE DISTAL TIP OF THE INNER CATHETER ALLEGEDLY BROKE AND DETACHED FROM THE ENDOVASCULAR STENT DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER PLACED A BARE METAL STENT TO SECURE THE DISTAL TIP AGAINST THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT, THE DISTAL TIP OF THE INNER CATHETER ALLEGEDLY BROKE AND DETACHED FROM THE ENDOVASCULAR STENT DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDE (HCP) PLACED A BARE METAL STENT TO SECURE THE DISTAL TIP AGAINST THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791824 FLAIR ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANZC0855 04049519008837

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention