BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 3031616 · Received April 2, 2013

    Report

    Report Number
    2953200-2013-00596
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (PARALYSIS). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY RUPTURED ANEURYSM, IRREGULARLY SHAPED AORTA). UNAPPROVED USE OF DEVICE (STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED THORACIC AORTIC ANEURYSM). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY RUPTURED ANEURYSM, IRREGULARLY SHAPED AORTA). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED THORACIC AORTIC ANEURYSM).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.5CM DIAMETER PRE-OPERATIVELY RUPTURED THORACIC AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR TREATMENT OF THE ANEURYSM; HOWEVER, THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN FOUR DAYS PRIOR TO SCHEDULED APPOINTMENT. A CT SCAN WAS DONE AND REVEALED THAT THE THORACIC ANEURYSM WAS RUPTURED. THE VALIANT STENT GRAFTS WERE IMPLANTED. IN ADDITION TO THE RUPTURED ANEURYSM THERE WAS ALSO A DISSECTION AND NARROWING OF THE THORACIC AORTA. THE THORACIC AORTA WAS 20 MM IN LENGTH PROXIMAL TO THE ANEURYSM. IT WAS 28.7 MM IN DIAMETER PROXIMAL TO THE ANEURYSM AND IMMEDIATELY PROXIMAL TO THE ANEURYSM IT WAS 27.5MM IN DIAMETER. THE DISTAL DIAMETER DIRECTLY BELOW THE ANEURYSM WAS 35.5MM AND 2 CM DISTAL TO THAT IT WAS 31.3MM AND AT THE CELIAC AXIS IT WAS 32.2MM. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED. THE LSA WAS COVERED IN ORDER TO SEAL THE ANEURYSM. IT WAS REPORTED THAT THE DAY FOLLOWING THE INDEX PROCEDURE THE PATIENT HAD PARALYSIS AND THE DECISION WAS MADE TO INSERT A LUMBAR DRAIN. THE PATIENT CONTINUED TO IMPROVE AND 11 DAYS POST IMPLANT THE PARALYSIS HAD COMPLETELY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135104 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01717355

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention