BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3140268 · Received May 31, 2013

    Report

    Report Number
    2953200-2013-01041
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 5, 2012
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DISSECTION. ANATOMY RELATED; DISEASE PROGRESSION. CONCLUSION: ANATOMY RELATED; DISEASE PROGRESSION.

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTA DISSECTION. THERE WERE ALSO ADJUNCTIVE PROCEDURES, LEFT ILIAC UNCOVERED SELF-EXPANDING STENT IMPLANTED AND OTHER ADJUNCTIVE PROCEDURES, THROMBECTOMY LEFT COMMON/EXTERNAL IA, INTERPOSITION GRAFT LEFT CFA. THE PATIENT HAD A DISSECTION RUPTURE, MALPERFUSION WITH LOWER LIMB ISCHEMIA. THE PRIMARY TEAR WAS IN THE PROXIMAL DESCENDING AORTA AND THERE WERE RE-ENTRY TEARS VISIBLE, TEAR ONE AT THE LEVEL OF THE OSTIUM OF THE LSA (INCL. 25 MM OF AORTA DISTAL TO OSTIUM), TEAR TWO AFTER THE OSTIUM AREA OF THE LSA AND WITHIN THE FIRST HALF OF THE DESCENDING AORTA. TEAR THREE IS BETWEEN THE CELIAC TRUNK AND THE RENAL ARTERIES, TEAR FOUR IS BETWEEN THE RENAL ARTERIES AND THE ABDOMINAL AORTIC BIFURCATION, AND TEAR FIVE BELOW THE AORTO-ILIAC JUNCTION OF THE PATIENT'S LEFT SIDE. THE MOST PROXIMAL TEAR IS AT THE LSA AND THE MOST DISTAL ASPECT OF THE DISSECTION IS IN THE LEFT EXTERNAL ILIAC ARTERY, TOTAL LENGTH 470 MM. THERE IS NO TORTUOSITY AND NO CALCIFICATION. ONE MONTH POST INDEX PROCEDURE IT WAS REPORTED THAT THERE IS PERFUSION OF THE FALSE LUMEN FILLS FROM RE-ENTRY AT THE VISCERAL AND FROM TYPE 1A ENDOLEAK (SMALL). THE INVESTIGATOR INDICATED THAT THE DEVICE INTEGRATION WAS MAINTAINED AND THE STENT GRAFT IS PATENT. SIX MONTHS POST INDEX PROCEDURE THE PERFUSION OF THE FALSE LUMEN IS FROM THE PRE-EXISTING TEAR. THE INVESTIGATOR INDICATED THAT THE DEVICE INTEGRATION WAS MAINTAINED AND THE STENT GRAFT IS PATENT. ONE YEAR POST INDEX PROCEDURE THE PERFUSION OF THE FALSE LUMEN IS FROM THE PRE-EXISTING TEAR BELOW LEVEL OF THE STENT GRAFT FEEDS NON-THROMBOSED FALSE LUMEN. THE INVESTIGATOR INDICATED THAT THE DEVICE INTEGRATION WAS MAINTAINED AND THE STENT GRAFT IS PATENT. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241303 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00808042

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR