BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2133359 · Received June 15, 2011

    Report

    Report Number
    2953200-2011-01150
    Event Type
    Death
    Date Received
    June 15, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (DEATH, ENDOLEAK, CARDIAC ARREST, DISSECTION), (PRE-EXISTING TYPE A DISSECTION), (COVERING THE CAROTID ARTERY). CONCLUSIONS: (PRE-EXISTING TYPE A DISSECTION), (COVERING THE CAROTID ARTERY).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 7.6 CM DIAMETER X 6.7 LONG THORACIC AORTIC ANEURYSM AT ZONE 2-3 APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL AORTIC NECK WAS 41 TO 43 MM IN DIAMETER AND 30 MM LONG; THE DISTAL NECK WAS 34 MM IN DIAMETER. THE ASCENDING AORTA HAD NO THROMBUS OR PLAQUE AND WAS NON-CALCIFIED. VESSELS WERE NON-TORTUOUS AND NON-CALCIFIED. THE PATIENT HAD A RCCA TO LCCA-AXILLARY ARTERY BYPASS PERFORMED FIVE DAYS PRIOR TO THE IMPLANTATION OF THE STENT GRAFT. THE TEVAR WAS PERFORMED WITH THE BLOOD PRESSURE KEPT AROUND 60 MMHG. A TALENT TAA (B)(4) (REF MFR# 2953200-2011-01150) WAS IMPLANTED INTO THE DISTAL SIDE OF THE ANEURYSM SUCCESSFULLY. THEN, A TALENT (B)(4) (REF MFR# 2953200-2011-01151) WAS INSERTED WITH ITS CONNECTING BAR ROTATED 120 DEGREES TOWARDS THE FRONT WALL OF THE AORTA, IN ORDER TO PREVENT THE BENT/EVERTED BARE SPRING. UNDER FLUOROSCOPY, THE EXPANSION AND IMPLANTATION OF THE STENT GRAFTS APPEARED SUCCESSFUL AND NORMAL W/O ANY ISSUES. MODELING WITH A RELIANT BALLOON WAS PERFORMED AT THE PROXIMAL AND DISTAL LANDING ZONES AND AT THE JUNCTIONAL ZONE W/O ANGIOGRAPHY WITH A CONTRAST AGENT DUE TO THE RENAL FAILURE. THEN, ANGIOGRAPHY CONFIRMED A SLIGHT ENDOLEAK AT THE LEFT SUBCLAVIAN; NO INTERVENTION WAS PERFORMED, AS IT WAS THOUGHT, THE ENDOLEAK WOULD RESOLVE AT A LATER TIME. THE CASE WAS DEEMED SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO ICU. FOR THE PREVENTION OF PARAPLEGIA AND FOR PROGRESSION OF URINARY OUTPUT, THE SYSTOLIC BP WAS SET TO 120-130 MMHG. AFTER AWAKENING FROM ANESTHESIA, THE PATIENT HAD A CLEAR CONSCIOUSNESS AND STABLE BLOOD PRESSURE. IT WAS REPORTED THAT THE NEXT DAY, THE PATIENT HAD A CARDIAC ARREST, AND CPR WAS STARTED, HOWEVER, AFTER AN HOUR OF CPR, THE PATIENT WAS UNABLE TO BE RESUSCITATED AND EXPIRED. THE PATHOLOGICAL FINDINGS FROM THE AUTOPSY WERE: THE BARE SPRING, POSITIONED AT THE BACK WALL AND SLIGHTLY AT THE INNER SIDE, AND AT THE OPPOSITE SIDE OF THE CONNECTING BAR, PERFORATED THE INTIMA AND MEDIA OF THE AORTA. THE ADVENTITIA WAS NOT PERFORATED. A RETROGRADE TYPE A DISSECTION FROM THE PERFORATION POINT WAS CONFIRMED AND RAN TO THE PERICARDIUM/HEART, AND 150CC OF BLOOD ACCUMULATED IN THE SPACE BETWEEN THE PERICARDIUM AND THE HEART. THE CAUSE OF DEATH WAS DIAGNOSED AS CARDIAC ARREST BY CARDIAC TAMPONADE. THE PHYSICIAN BELIEVES THAT THE PERFORATION MIGHT HAVE OCCURRED BY THE EXPANSION OF THE BARE SPRING, THOUGH A PERFORATION OR RTAD WAS NOT NOTICED BY ANGIOGRAPHY, AS THERE WAS NO CONTRAST INTO A FALSE LUMEN. THE PHYSICIAN COMMENTED THAT THE RTAD OCCURRED FROM THE PERFORATION POINT AFTER CLOSING TEVAR AND THAT IT EXPANDED TO THE HEART GRADUALLY AND LED TO THE SUDDEN CHANGE OF THE PATIENT'S CONDITION. THE TEVAR WAS PERFORMED AS PLANNED AND WAS SUCCESSFUL UNDER FLUOROSCOPY AND ANGIOGRAPHY, AND THERE WAS NO ABNORMAL TECHNIQUE. AN INTERNAL REVIEW OF THE PRE-OPERATIVE 3D IMAGES AND INTRAOPERATIVE ANGIOGRAM/FILMS WAS PERFORMED. THE CAUSE OF THE TYPE A DISSECTION COULD NOT BE CONFIRMED. A POSSIBLE PRE-EXISTING TYPE A DISSECTION IS SEEN ON THE PRE-OP CTA DATED TWO MONTHS PRIOR TO STENT GRAFT PROCEDURE. STENT GRAFT COVERAGE OF THE CAROTID ARTERY IS SEEN; NO MISALIGNED DEPLOYMENT OR OTHER DEVICE ISSUES ARE OBSERVED FOLLOWING IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00822541

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death