BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT CAPTIVIA

    MDR report key: 3194389 · Received June 27, 2013

    Report

    Report Number
    2953200-2013-01212
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 12, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN); INHERENT RISK OF PROCEDURE (DISSECTION, CARDIAC TAMPONADE, DEATH). CONCLUSIONS: (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN); KNOWN INHERENT RISK OF A PROCEDURE (DISSECTION, CARDIAC TAMPONADE, DEATH).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE STUDY INVESTIGATOR ASSESSED THIS EVENT TO BE NOT DEVICE RELATED AND NOT PROCEDURE RELATED. A REVIEW OF FILMS PRE-IMPLANT SHOWS A 5CM MAX DIAMETER TAA IN THE ARCH; DISTAL TO THE LSA. THE AORTIC DIAMETER (FLOW LUMEN) WITHIN THE ASCENDING THORACIC IS 50MM, AND NEAR THE LSA IS 33MM. THERE IS ALSO A 7CM TAA IN THE DESCENDING THORACIC AORTA. DISTAL TO THE TAA THE THORACIC TAKES A MODERATE BEND; THE AORTIC DIAMETER MEASURES 28 - 30MM, AND THEN INCREASES TO 40MM PROXIMAL TO THE CELIAC ARTERY. THERE IS ALSO A 4.5CM MAX AAA WHICH CONTAINS THROMBUS. POST-IMPLANT X-RAYS SHOW THAT 2 TALENT DEVICES WERE PLACED FROM THE ARCH EXTENDING INTO THE DESCENDING THORACIC AORTA. THE DISTAL STENT GRAFT EXTENDS APPROXIMATELY 5CM (2 STENT) BEYOND THE PROXIMAL MAIN DEVICE. THE DEVICES ARE GRADUALLY ANGULATED APPROX 180DEG FROM PROXIMAL TO DISTAL END. OF NOTE, THE C-BAR OF THE PROXIMAL MAIN APPEARS TO HAVE BEEN ALIGNED (PROXIMAL TO DISTAL) FROM THE INFERIOR TO THE ANTERIOR SIDE OF THE ARCH, AND A SUBSTANTIAL LOOP/BEND IS SEEN AT ITS MID-LENGTH AS IT COURSES DISTALLY. NO STENT OR C-BAR FRACTURE IS OBSERVED. CTA'S 2 WEEKS POST-IMPLANT SHOW THAT THE DEVICE WAS POSITIONED PROXIMALLY FROM JUST DISTAL TO THE LCCA (COVERING THE LSA), EXTENDING DISTALLY ACROSS THE ARCH INTO THE DESCENDING THORACIC AORTA. THE STENT GRAFT WAS CONTINUOUSLY CURVED ITS ENTIRE LENGTH, BUT NOT KINKED. THE TAA DIAMETER IN THE ARCH WAS APPROXIMATELY 5CM MAX, AND THE DISTAL TAA IN THE DESCENDING THORACIC WAS 7.5 - 8.0CM MAX. THE THORACIC DIAMETER JUST PROXIMAL TO THE STENT GRAFT WAS 38MM, AND JUST DISTAL TO THE DISTAL END WAS 34MM. THE 4.5CM MAX AAA WAS ALSO OBSERVED. NO ENDOLEAK WAS SEEN; THE STENT GRAFT WAS PATENT WITH NO THROMBUS OBSERVED. THE C-BAR OF PROXIMAL MAIN WAS AGAIN SEEN LOOPED AT THE STENT GRAFT MID-LENGTH. NO FRACTURE OR OTHER STENT GRAFT ISSUES WERE OBSERVED. ADDITIONAL IMAGES WERE NOT AVAILABLE (PT LOST TO FOLLOW-UP AND SUBSEQUENTLY EXPIRED) THEREFORE THE ANEURYSMS MORPHOLOGY AND STENT GRAFT IN-VIVO CONFIGURATION JUST PRIOR TO AUTOPSY COULD NOT BE DETERMINED. THE CAUSE OF THE DISSECTION, OR ANY POSSIBLE DEVICE RELATIONSHIP TO THE EVENTS, COULD NOT BE DETERMINED. THE THORACIC AORTIC SPECIMEN WITH STENT GRAFT WAS RETURNED FOR EVALUATION FOLLOWING AUTOPSY. THE SPECIMEN WAS RETURNED TRANSECTED APPROXIMATELY 5 MM PROXIMAL TO THE PROXIMAL BARE SPRINGS, AND 5 CM DISTAL TO THE DISTAL END OF THE DISTAL MAIN. THE STENT GRAFT WAS POSITIONED WITH THE PROXIMAL BARE SPRINGS JUST PROXIMAL TO PATENT LCCA. THE PROXIMAL MARGIN OF THE STENT GRAFT FABRIC WAS COVERING THE PATENT LSA. SIGNIFICANT AMOUNTS OF THROMBUS WERE SEEN WITHIN THE DISTAL SECTION OF THE PROXIMAL MAIN WHERE IT OVERLAPS AND ANGULATES WITH THE DISTAL MAIN. THE CAUSE OF THE THROMBUS COULD NOT BE DETERMINED; IT IS UNCLEAR IF THIS OCCURRED PRIOR TO OR POST-DISSECTION. THE BARE SPRINGS APPEARED TO BE FIRMLY EMBEDDED INTO THE AORTA, AND IN SOME AREAS WERE INCORPORATED BY THE TISSUE. NO GROSS TISSUE ABNORMALITIES WERE OBSERVED WITHIN THE AORTA OR NEAR THE BARE SPRINGS. PRIOR TO REMOVAL OF THE STENT GRAFT FROM THE AORTA, ONE OF THE BARE SPRINGS APICES WAS OBSERVED FRACTURED; IT COULD NOT BE DETERMINED IF THIS FRACTURE OCCURRED IN-VIVO OR DURING AUTOPSY. FILMS 2 WEEKS POST-IMPLANT SHOWED THAT THE PROXIMAL BARE SPRING WAS NOT FRACTURED. THE BARE SPRINGS WERE POSITIONED APPROXIMATELY 11 CM DISTAL TO THE AORTIC VALVE; DISTAL TO THE DISSECTION LOCATION (6.6CM) REPORTED AT AUTOPSY. AFTER REMOVAL OF THE THORACIC SPECIMEN FROM THE STENT GRAFT AND REMOVAL OF ALL TISSUE, THE CLEANED STENT GRAFT WAS EXAMINED. THE DISTAL MAIN EXTENDED APPROXIMATELY 2 STENTS FROM THE PROXIMAL MAIN; 3 STENTS WERE OVERLAPPING. THE CONNECTING BAR OF THE PROXIMAL MAIN WAS FOUND TO HAVE A SUBSTANTIAL BEND NEAR THE 4TH COVERED STENT. THIS BEND WAS ALSO SEEN IN THE RETURNED X-RAYS SEVERAL DAYS POST-IMPLANT, AND APPEARS TO HAVE BEEN CAUSED BY PLACEMENT OF THE STENT GRAFT WITHIN THE ARCH WITH THE ORIENTATION OF THE C-BAR TO THE INFERIOR AND ANTERIOR SIDE, INSTEAD OF ALONG THE RECOMMENDED OUTSIDE CURVATURE. FROM THE EXAMINATION OF THE RETURNED DEVICES, THE CAUSE OF THE DISSECTION, AND ANY POSSIBLE DEVICE RELATIONSHIP TO THE EVENTS, COULD NOT BE DETERMINED. IN ADDITION TO THE FRACTURED BARE SPRING, SEVERAL 1 MM ¿ 3MM LENGTH ABRASION OR PUNCTURE FABRIC TEARS WERE OBSERVED ON BOTH DEVICES. THE CAUSE OF THESE TEARS COULD NOT BE DETERMINED. SEVERAL LARGER FABRIC CUTS, LIKELY OCCURRING DURING AUTOPSY OR DURING REMOVAL OF THE DEVICE FROM THE AORTA, WERE ALSO OBSERVED ON BOTH DEVICES. NO EVIDENCE OF ANY STENT GRAFT RELATED ISSUES WERE SEEN ON THE FILMS IMMEDIATELY POST-IMPLANT; HOWEVER, MORE RECENT IMAGES WERE NOT AVAILABLE AS THE PATIENT WAS LOST TO FOLLOW-UP, THEREFORE THE ANEURYSM MORPHOLOGY AND STENT GRAFT IN-VIVO CONFIGURATION JUST PRIOR TO THE DISSECTION COULD NOT BE EVALUATED. THE STENT GRAFTS WERE ALSO VERIFIED TO HAVE MET ALL TALENT CAPTIVIA MANUFACTURING SPECIFICATIONS PRIOR TO BEING SHIPPED.

    Description of Event or Problem · 1

    A TALENT CAPTIVIA TAA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SYMPTOMATIC FUSIFORM THORACIC AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 75 MM. THE PROXIMAL AORTA WAS 37 MM IN DIAMETER AND 40 MM IN LENGTH. THE DISTAL AORTA WAS 33 MM IN DIAMETER. RIGHT AND LEFT COMMON ILIAC ARTERIES WERE 9MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY DIAMETER WAS 6 MM, AND THE LEFT WAS 5.5 MM. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 6 MM IN DIAMETER. THE ACCESS VESSELS HAD NO CALCIFICATION AND THE AORTIC NECK HAD NO MURAL THROMBUS. THE AORTA WAS MODERATELY TORTUOUS. THE ABDOMINAL AORTA DEMONSTRATED BILOBED ANEURYSMAL DILATATION WITH THE SUPRARENAL ABDOMINAL AORTA MEASURING 4.9 X 5.7 CM AND THE INFRARENAL ASPECT MEASURING 4.5 X 4.7 CM. THE CELIAC ORIGIN WAS 50% STENOSED. IT WAS REPORTED THAT AN ILIAC CONDUIT WAS USED TO DELIVER THE DEVICE. THE PROXIMAL STENT GRAFT WAS IMPLANTED IN ZONE 2, AND THE DISTAL STENT GRAFT WAS IMPLANTED IN ZONE 4. THE LEFT SUBCLAVIAN ARTERY WAS PARTIALLY AND INTENTIONALLY COVERED. THERE WAS SOME FLOW IN THE SUBCLAVIAN ARTERY BUT DUE TO THE FACT THAT THERE WAS A GOOD SEAL PROXIMAL TO THE ANEURYSM, THE PHYSICIAN ELECTED NOT TO EMBOLIZE THE LEFT SUBCLAVIAN ARTERY. NO REVASCULARIZATION PROCEDURES WERE PERFORMED. NO ADVERSE EVENTS OR TECHNICAL OBSERVATIONS WERE REPORTED AT THE TIME OF THE PROCEDURE. THE PATIENT DID REPORT COMPLAINTS OF CONTINUED CHEST PAINT AT THE 1 MONTH FOLLOW-UP VISIT. THE INVESTIGATOR REPORTED THAT THE CHEST PAINT WAS ATTRIBUTED TO THE TAA PRIOR TO THE TEVAR; THE ETIOLOGY OF THE PAIN POST TEVAR WAS UNKNOWN. THE ONE MONTH FOLLOW-UP CT REVEALED NO COMPLICATIONS. THE INVESTIGATOR REPORTED THAT THE SUBJECT HAD BEEN NON-COMPLIANT WITH FOLLOW-UP SINCE THE 30 DAY POST-OPERATIVE CHECKUP. THE MEDICAL EXAMINER NOTIFIED THE STUDY INVESTIGATOR APPROXIMATELY 20 MONTHS POST IMPLANT THAT THE PATIENT HAD EXPIRED. IT WAS REPORTED THAT THE PATIENT COLLAPSED AT WORK. THE MEDICAL EXAMINER TOOK CUSTODY OF THE BODY AND PERFORMED AN AUTOPSY. THE CAUSE OF DEATH WAS REPORTED BY THE MEDICAL EXAMINER TO BE CARDIAC TAMPONADE DUE TO AORTIC DISSECTION DUE TO ATHEROSCLEROTIC CARDIOVASCULAR DISEASE. A LACERATION OF THE INTIMAL SURFACE OF THE ASCENDING AORTA WAS OBSERVED. A LACERATION OF THE ADVENTITIAL SURFACE OF THE AORTA AND PERICARDIAL FAT WAS OBSERVED WITH 450 ML OF BLOOD AND BLOOD CLOTS IN THE PERICARDIAL SAC. THE RELATIONSHIP OF THE DEATH TO THE PROCEDURE AND DEVICE ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293947 TALENT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00840347

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Death