BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2222812 · Received August 12, 2011

    Report

    Report Number
    2953200-2011-01435
    Event Type
    Death
    Date Received
    August 12, 2011
    Date of Event
    September 13, 2012
    Report Date
    September 11, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (RUPTURE); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; CONTINUE DISEASE PROGRESSION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; CONTINUE DISEASE PROGRESSION).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK), (IMPLANTING THE STENT GRAFT IN THE PROXIMAL THORACIC AORTA). CONCLUSION: (IMPLANTING THE STENT GRAFT IN THE PROXIMAL THORACIC AORTA).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED FROM THE PHYSICIAN THAT POST-OPERATIVE FOLLOW-UP CT DATA SHOWED AN ENDOLEAK. IT WAS ORIGINALLY DEEMED TO BE TYPE III EL, BUT IT WAS DETERMINED TO BE TYPE IA EL THROUGH SEVERAL TIMES CT CHECK TWO YEARS AGO. ONE YEAR AGO, THE PATIENT WAS TAKEN TO HOSPITAL DUE TO ANEURYSM RUPTURE BECAUSE OF EXPANSION OF ANEURYSM DIAMETER WHOSE SIZE WAS 7. 3 CM IN DIAMETER, DUE TO THE UNTREATED TYPE IA ENDOLEAK. THE RUPTURED ANEURYSM BLOOD FLOWED INTO BRONCHUS AND PATIENT HEMORRHAGED. THE PATIENT EXPIRED THE FOLLOWING DAY DUE TO ANEURYSM RUPTURE. AT THE TIME OF DEVICE IMPLANT, TOUCH-UP WAS GIVEN WITHOUT LEAK AND PROCEDURE WAS COMPLETED. THE ENDOLEAK WAS APPEARED AT 1 MONTH LATER FROM TEVAR, BUT THE CAUSE WAS UNKNOWN. THIS WAS THE CASE THAT DOCTOR HAD A TALK WITH THE PATIENT AND IT WAS CONSIDERED RISKS IN ADDITIONAL TREATMENT BECAUSE OF HIS OLD AGE AND HAVING OTHER DISEASES, THEN IT WAS DECIDED NOT TO HAVE ADDITIONAL TREATMENT, BUT TO HAVE CONSERVATIVE TREATMENT FOLLOWING HIS STRONG REQUEST. THE CAUSE OF DEATH WAS ANEURYSM RUPTURE. PATIENT CONDITION WAS NOT GOOD HEALTH AND PREFERRED TO HAVE CONSERVATIVE TREATMENT, SO THAT T HERE WAS NO OTHER EFFECTIVE MEANS.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 6.2 CM IN DIAMETER X 10 CM LONG THORACIC AORTIC ANEURYSM IN ZONE 1 APPROX 9 MONTHS AGO. THE PROXIMAL AORTIC NECK DIAMETER WAS 42 MM, AND THE DISTAL AORTIC NECK WAS 34 MM IN DIAMETER. THERE WAS NO CALCIFICATION, BUT THERE WAS MILD THROMBUS AT THE DISTAL AORTIC NECK. IT WAS REPORTED THAT APPROX 3 WEEKS POST-IMPLANTATION, AN UNK ENDOLEAK, POSSIBLY A DISTAL TYPE I ENDOLEAK, A TYPE II ENDOLEAK, OR A JUNCTIONAL TYPE III ENDOLEAK BETWEEN THE DISTAL (B)(4) STENT GRAFT (MFR REPORT # 2953200-2011-01432) AND THE PROXIMAL (B)(4) STENT GRAFT (MFR REPORT # 2953200-2011-01433) WAS SEEN VIA CT. THE DIAMETER OF THE ANEURYSM HAS NOT BEEN INCREASING; THEREFORE, THE PHYSICIAN ELECTED TO MONITOR THE PT WITHOUT ANY INTERVENTION. ON AN UNK DATE, A PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED, AND APPROX 1 MONTH AGO, THE PT RETURNED FOR AN INTERVENTION, AS THE PHYSICIAN PERFORMED COIL EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY FOR A CONFIRMED TYPE II ENDOLEAK. AFTER THE EMBOLIZATION, THE PROXIMAL TYPE I ENDOLEAK WORSENED. THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING A (B)(4) STENT GRAFT (MFR REPORT # 2953200-2011-01434) PROXIMALLY; HOWEVER, THE BARE SPRING INVERTED, AND THEN THE PHYSICIAN PULLED BACK ON THE DELIVERY SYSTEM TO CORRECT THE INVERTED BARE SPRING. ALTHOUGH THE BARE SPRING WAS CORRECTED, THE STENT GRAFT MOVED FROM ITS INTENDED PLACEMENT. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER (B)(4) STENT GRAFT (MFR REPORT # 2953200-2011-01435); HOWEVER, THE BARE SPRING INVERTED, AND THE PHYSICIAN PUSHED AND PULLED ON THE DELIVERY SYSTEM TO TRY TO CONNECT THE BARE SPRING'S POSITION. THE PHYSICIAN WAS UNABLE TO CORRECT THE BARE SPRING, WHICH REMAINED MISALIGNED, AND THE PROXIMAL TYPE I ENDOLEAK REMAINED. NO FURTHER INTERVENTION WAS PERFORMED FOR THE PROXIMAL TYPE I ENDOLEAK. THERE WAS ALSO A DISTAL TYPE I ENDOLEAK; THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING A (B)(4) STENT GRAFT DISTALLY, WHICH SUCCESSFULLY RESOLVED THE DISTAL TYPE I ENDOLEAK. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00541197

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death