BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT

    MDR report key: 5346253 · Received January 6, 2016

    Report

    Report Number
    3004753364-2016-00001
    Event Type
    Injury
    Date Received
    January 6, 2016
    Date of Event
    November 14, 2015
    Report Date
    February 23, 2016
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION IS IN PROCESS AND A FINAL REPORT SHALL BE FILED AS PER ITS CONCLUSION.

    Additional Manufacturer Narrative · 1

    A FULL REVIEW OF THE DEVICE HISTORY RECORD FOR THESE DEVICES HAS BEEN CARRIED OUT WITH NO ANOMALIES IDENTIFIED; PRODUCT WAS MANUFACTURED AND RELEASED FOR SALE IN ACCORDANCE WITH SPECIFICATIONS. THERE IS NO INFORMATION TO SUGGEST THAT THE DEVICES HAVE NOT MET THE FINAL RELEASE CRITERIA. ADDITIONALLY, A REVIEW OF AN IN-PROCESS VIDEO TAKEN AFTER LOADING OF THE MAIN BODY DEVICE WAS PERFORMED. THIS VIDEO ACTS AS A RECORD THAT THE DEVICE MEETS THE INSPECTION REQUIREMENTS FOR A LOADED IMPLANT. THIS VIDEO CONFIRMED THAT THE DEVICE WAS PACKED INTO THE DELIVERY SYSTEM IN ACCORDANCE TO COMPANY WORK INSTRUCTION 211, INSPECTION OF PACKED SG-HBB AND SG-HPE DEVICES. ADDITIONAL INFORMATION AS OF 21 APR 16: THE IMPLANT WAS RETURNED TO LOMBARD MEDICAL FOR REVIEW, HOWEVER THE CLINICIAN HAS CUT THROUGH THE STENT GRAFT ALONG ITS LENGTH AND AROUND THE PROXIMAL AXIS IN ORDER TO AID REMOVAL. A REVIEW OF THE PROXIMAL END OF THE STENT GRAFT, WHERE THE BARBS ARE LOCATED HAS IDENTIFIED PRESENCE OF 2 BARB SETS WHICH REMAIN INTACT. ON THE OPPOSITE SIDE OF THE STENT GRAFT, THE BARBS ARE PRESENT HOWEVER, THE HOOK PART OF EACH OF THE BARBS HAS FRACTURED. IT IS PROBABLE THAT NECK DILATATION DUE TO DISEASE PROGRESSION HAS LED TO ADDITIONAL STRESS ON THE BARB TIPS LEADING TO FRACTURE AND SUBSEQUENT MIGRATION. THERE HAS BEEN NO REPORT OF ENDOLEAK IN THIS CASE - THE DEVICE WAS EXPLANTED AS A RESULT OF THE MIGRATION AND AT THE TIME OF EXPLANT, THE ANEURYSM WAS STILL EXCLUDED.

    Additional Manufacturer Narrative · 1

    DHR REVIEW: A FULL REVIEW OF THE DEVICE HISTORY RECORD FOR THESE DEVICES HAS BEEN CARRIED OUT WITH NO ANOMALIES IDENTIFIED; PRODUCT WAS MANUFACTURED AND RELEASED FOR SALE IN ACCORDANCE WITH SPECIFICATIONS. THERE IS NO INFORMATION TO SUGGEST THAT THE DEVICES HAVE NOT MET THE FINAL RELEASE CRITERIA. VIDEO REVIEW: ADDITIONALLY, A REVIEW OF AN IN PROCESS VIDEO TAKEN AFTER LOADING OF THE MAIN BODY DEVICE WAS PERFORMED. THIS VIDEO ACTS AS A RECORD THAT THE DEVICE MEETS THE INSPECTION REQUIREMENTS FOR A LOADED IMPLANT. THIS VIDEO CONFIRMED THAT THE DEVICE WAS PACKED INTO THE DELIVERY SYSTEM IN ACCORDANCE TO COMPANY WORK INSTRUCTION 211, INSPECTION OF PACKED SG-HBB AND SG-HPE DEVICES.

    Description of Event or Problem · 1

    THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2012. THE EXPLANT WAS PERFORMED ON UNKNOWN DATE.DEVICE WAS WELL PLACED. INITIAL OVER-SIZE WAS WITHIN IFU, TOWARD THE LOW END OF THE RANGE (13.5%) - TABLE BELOW:DATE EQUIVALENT CIRCULAR DIAMETER %OVERSIZE(B)(6) 2012 23.8MM 13.5%(B)(6) 2012 23.9MM 12.9%(B)(6) 2014 25.9MM 4.1%(B)(6) 2015 26.1MM 3.6%MOST LIKELY DEPLOYED UNDER TENSION, CAUSING COMPRESSION OF LUMEN AT THE AORTIC BEND. THE LUMEN OF THE AORTA JUXTARENALLY EXPANDED LEAVING OVERSIZE <5%. BARB FRACTURED. MIGRATION APPROX 4MM.IMPLANTS USED IN THIS CASE:MODEL NUMBER LOT NUMBER EXPIRY DATE MANUFACTURE DATESG-HBB-26-126-63-12 BE29253-1 11 AUG 2013 11 AUG 2011SG-HBL-64-20 BA33296-1 10 JAN 2014 10 JAN 2012SG-HBL-106-20 BA27040-1 17 APR 2013 17 APR 2011

    Description of Event or Problem · 1

    THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2012. THE EXPLANT WAS PERFORMED ON UNKNOWN DATE. DEVICE WAS WELL PLACED. INITIAL OVER-SIZE WAS WITHIN IFU, TOWARD THE LOW END OF THE RANGE (13.5%) - (B)(6). MOST LIKELY DEPLOYED UNDER TENSION, CAUSING COMPRESSION OF LUMEN AT THE AORTIC BEND. THE LUMEN OF THE AORTA JUXTARENALLY EXPANDED LEAVING OVERSIZE <5%. BARB FRACTURED. MIGRATION APPROX 4MM. IMPLANTS USED IN THIS CASE: MODEL: SG-HBB-26-126-63-12, LOT: BE29253-1, EXP DATE: 11 AUG 2013, MFG DATE: 11 AUG 2011; MODEL: SG-HBL-64-20, LOT: BA33296-1 , EXP DATE: 10 JAN 2014 , MFG DATE: 10 JAN 2012; MODEL: SG-HBL-106-20 , LOT: BA27040-1 , EXP DATE: 17 APR 2013 , MFG DATE: 17 APR 2011.

    Description of Event or Problem · 1

    THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2012. DUE TO MIGRATION, AN EXPLANT WAS PERFORMED ON (B)(6) 2015. DEVICE WAS WELL PLACED. INITIAL OVER-SIZE WAS WITHIN IFU, TOWARD THE LOW END OF THE RANGE (13.5%) - TABLE BELOW: DATE: (B)(6) 2012, EQUIVALENT CIRCULAR DIAMETER: 23.8MM, % OVERSIZE: 13.5%; DATE: (B)(6) 2012, EQUIVALENT CIRCULAR DIAMETER: 23.9MM, % OVERSIZE: 12.9%; DATE: (B)(6) 2014, EQUIVALENT CIRCULAR DIAMETER: 25.9MM, % OVERSIZE: 4.1%; DATE: (B)(6) 2015, EQUIVALENT CIRCULAR DIAMETER: 26.1MM, % OVERSIZE: 3.6%. MOST LIKELY DEPLOYED UNDER TENSION, CAUSING COMPRESSION OF LUMEN A THE AORTIC BEND. THE LUMEN OF THE AORTA JUXTARENALLY EXPANDED LEAVING OVERSIZE <58%. BARB FRACTURED AND MIGRATION APPROX 4MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7480 AORFIX AAA FLEXIBLE STENT GRAFT ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG-HBB-26-126-63-12 BE29253-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention