BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3491740 · Received November 27, 2013

    Report

    Report Number
    2953200-2013-02345
    Event Type
    Death
    Date Received
    November 27, 2013
    Date of Event
    November 2, 2013
    Report Date
    December 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (DEATH); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TORTUOUS ANATOMY); (CAUSE OF EVENT IS UNKNOWN). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (DEATH); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TORTUOUS ANATOMY); (CAUSE OF EVENT IS UNKNOWN); ANOTHER DEVICE CAUSED FAILURE.

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-EXISTING DISSECTION PLANE). DEVICE FAILURE RELATED TO PATIENT CONDITION (PRE-EXISTING DISSECTION PLANE).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. THE PROXIMAL NECK WAS 42 MM IN DIAMETER. THE PATIENT HAD BEEN TRANSFERRED FROM ANOTHER HOSPITAL. IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS POSITIONING DIFFICULTY AND VESSEL RUPTURE DURING ADVANCEMENT OF THE DELIVERY CATHETER WHICH ULTIMATELY LED TO DEATH DURING THE PROCEDURE. IT WAS REPORTED THAT THE FIRST DEVICE (42/42/150) WAS DEPLOYED WITH NO PROBLEMS. WHEN THEY WENT TO PLACE THE SECOND DEVICE JUST PROXIMAL 46X46X150, THE PHYSICIAN MET RESISTANCE WHEN TRACKING THROUGH THE GRAFT. THE PROXIMAL PORTION OF THE 46 GRAFT WAS BETWEEN THE LEFT SUBCLAVIAN ARTERY AND THE PROXIMAL PORTION OF THE 42/42/150 FABRIC. THE DISTAL PORTION WAS INSIDE OF THE 42/42/150 GRAFT. THE ANATOMY WAS VERY TORTUOUS. WHILE ADVANCING THE 46/46/150 OVER ANOTHER MANUFACTURER¿S WIRE, THE DEVICE RETRACTED DISTALLY (TOWARDS THE CELIAC) AND RUPTURED JUST BELOW THE ORIGINAL GRAFT MATERIAL OF THE 42/42/150. THE 46/46/150 WAS REMOVED, NOT DEPLOYED. ANOTHER MANUFACTURER¿S BALLOON WAS USED TO OCCLUDE THE AORTA. ANOTHER ANGIOGRAM WAS TAKEN TO DETERMINE THE LOCATION OF THE RUPTURE. THE PHYSICIAN SAW THAT IT WAS JUST DISTAL TO THE 42 GRAFT. THE PATIENT HAD NO PRESSURE. ANESTHESIA CAME IN AND BEGAN CPR. THE PHYSICIAN WENT UP WITH A 46/46/100 VALIANT STENT GRAFT TO TRY TO CONTAIN THE RUPTURE. THE PHYSICIAN PLACED THE GRAFT PROXIMAL TO THE CELIAC ARTERY AND WELL INTO THE ORIGINAL 42/42/150 GRAFT. THE PRESSURE EVER CAME BACK AND A CODE WAS CALLED. THE PHYSICIAN WAS NOT SURE THE CAUSE OF THE RUPTURE; HOWEVER, HE DID MENTION THAT THERE COULD HAVE BEEN A DISSECTION PLANE THAT WAS AGGRAVATED UPON ADVANCEMENT OF THE SECOND DEVICE BUT THAT WAS NOT CONFIRMED. THERE WAS EXCESSIVE FORCE USED BY THE PHYSICIAN WHEN HE ADVANCED THE DEVICE. THE RUPTURE WAS NOT NEAR THE TAA THAT THEY WERE TREATING IT WAS DISTAL TO THE FIRST PIECE THAT WAS PUT IN- AND OCCURRED BETWEEN THE MOST DISTAL PORTION OF THE FIRST GRAFT AND THE CELIAC ARTERY. THE PATIENT EXPIRED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT HE THOUGHT THE DISSECTION PLANE WAS PRE-EXISTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618399 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01044031

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death