BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3100480 · Received May 8, 2013

    Report

    Report Number
    2953200-2013-00859
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    February 14, 2014
    Report Date
    March 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK ) PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BACK/CHEST PAIN AND HYPERTENSION PRE-OPERATIVELY. IT WAS REPORTED THAT A RECENT THE ANGIOGRAM REVEALED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK PROXIMAL AND DISTAL TYPE I ENDOLEAK. IT IS POSSIBLE THAT THE TYPE B DISSECTION WAS NOT COMPLETELY COVERED AT THE TIME OF THE INDEX PROCEDURE, RESULTING IN THE CONTINUATION OF THE DISSECTION BOTH DISTALLY AND PROXIMALLY. THE PHYSICIAN ELECTED TO IMPLANT A 42X38X150 AND DISTALLY 36X32X150, SUCCESSFULLY RESOLVING THE TYPE I ENDOLEAK AND THE STENT GRAFTS ARE EXTENDED BEYOND THE TYPE B DISSECTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT THE PATIENT RECOVERED FROM ACUTE KIDNEY INJURY DUE TORHABDOMYOLYSIS, CONTRAST NEPHROPATHY ISCHEMIA, AND RENAL ISCHEMIA THREE MONTHS POST INDEX PROCEDURE. THE THREE YEAR FOLLOW UP REVEALED THAT THERE WAS PERFUSION OF THE FALSE LUMEN FROM AN UNKNOWN LOCATION. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT.

    Description of Event or Problem · 1

    CORRECTION FOR THIS CASE, THE INFORMATION; IT WAS REPORTED THAT THE PATIENT RECOVERED FROM ACUTE KIDNEY INJURY DUE TO RHABDOMYOLYSIS, CONTRAST NEPHROPATHY ISCHEMIA, AND RENAL ISCHEMIA THREE MONTHS POST INDEX PROCEDURE, THIS INFORMATION NEEDS TO REDACTED, AS THIS EVENT WAS INADVERTENTLY REPORTED FOR THIS PATIENT HOWEVER THE EVENT WAS NOT RELATED TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201915 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01138027

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention