BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 12521761 · Received September 23, 2021

    Report

    Report Number
    9612164-2021-03675
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    July 26, 2021
    Report Date
    September 23, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED NOTIFICATION OF A LITERATURE ARTICLE WHICH MENTIONS USE OF MEDTRONIC DEVICES ENTITLED: "ISCHEMIC MONOMELIC NEUROPATHY OBSCURED BY DIABETES AND STROKE AFTER THORACIC ENDOVASCULAR AORTIC REPAIR" AHMAD J. ABDULSALAM, MD, BIJU GOPINATH, MD, BUTHAINA M. ALKANDARI, MD, FFRRCSI, DIAA SHEHAB, MD, FRCP, SALEM A. ALKANDARI, MD, FBPRM DOI: 10.17712/NSJ.2021.3.20200023 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR AN EMERGENCY TEVAR PROCEDURE AFTER A TRAFFIC ACCIDENT. DURING THE REPAIR, DUE TO A NON-SUFFICIENT LENGTH OF THEPROXIMAL LANDING ZONE, THE LSA WAS COVERED. THE PROXIMAL LANDING ZONE WAS SET TO BE BETWEEN THE LEFT COMMON CAROTID ARTERY AND THE LSA. THE VALIANT STENT GRAFT (22 MM×152 MM) WAS SUBSEQUENTLY FULLY DEPLOYED. AN ANGIOGRAM SHOWED PERSISTENT SLOW FILLING OF THE LSA FROM THE ARCH, WITH NO EVIDENCE OF ENDOLEAK OR ANTEGRADE FLOW AND LATE FLOW WAS NOTED INTO THE LSA FROM THE LEFT VERTEBRAL ARTERY. THE PATIENT WAS MOVED TO ICU POST PROCEDURE DUE TO HYPOTENSION. ONE DAY LATER, THE PATIENT COMPLAINED OF LEFT-SIDED WEAKNESS, NUMBNESS, AND PAIN IN THE UPPER LIMB, ALONG WITH REDUCED GRIP STRENGTH AND ARM AND WRIST MOVEMENT. . SENSATION WAS ALSO IMPAIRED IN THE WHOLE LEFT UPPER LIMB, ACCOMPANIED BY A STOCKING-GLOVE PATTERN IN ALL FOUR LIMBS. A BRAIN CT SHOWED MULTIPLE ILL-DEFINED HYPODENSITIES. A FOLLOW-UP MRI REVEALED THREE ACUTE LACUNAR INFARCTIONS IN THE RIGHT PARIETAL AND LEFT OCCIPITAL LOBES, THE PATIENT WAS THEREFORE DIAGNOSED WITH A STROKE AFTER THE TEVAR. ONE MOTH POST IMPLANT, ISCHEMIC NEUROMUSCULAR INJURY TO THE LEFT UPPER LIMB, WITH SUPERIMPOSED AXONAL DISTAL POLYNEUROPATHY. THEREFORE, THE PATIENT WAS DIAGNOSED WITH BOTH DIABETIC NEUROPATHY AND ISCHEMIC MONOMELIC NEUROPATHY (IMN). AFTER A ONE-YEAR FOLLOW-UP, THE MOTOR WEAKNESS IMPROVED MILDLY. DESPITE BEING ON A HIGH DOSE OF GABAPENTIN, THE PATIENT STILL COMPLAINED OF NEUROPATHIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415498 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND VAMF2622C150TU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R