BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT BIFURCATED STENT GRAFT

    MDR report key: 1966135 · Received January 19, 2011

    Report

    Report Number
    2953200-2011-00140
    Event Type
    Death
    Date Received
    January 19, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 20, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: DEATH, RUPTURED ANEURYSM. LOT NUMBER, IMPLANT INFO WERE NOT PROVIDED. EVAL CONCLUSIONS: LOT NUMBER, IMPLANT INFO WERE NOT PROVIDED. RATE AND PREDICTABILITY OF GRAFT RUPTURE AFTER ENDOVASCULAR AND OPEN ABDOMINAL AORTIC ANEURYSM REPAIR. (B)(4).

    Description of Event or Problem · 1

    JOURNAL ARTICLE ENTITLED: RATE AND PREDICTABILITY OF GRAFT RUPTURE AFTER ENDOVASCULAR AND OPEN ABNORMAL AORTIC ANEURYSM REPAIR. DATA FROM THE EVAR TRIALS. THOMAS R. WYSS, MD, LOUISE C. BROWN, PHD, JANET T. POWELL, MD, AND ROGER M. GREENHALGH, MA, MD, MCHIR, FRCS. FROM THE VASCULAR SURGERY RESEARCH GROUP, IMPERIAL COLLEGE, LONDON, UNITED KINGDOM. OBJECTIVE: TO ASSESS THE RATE AND FACTORS ASSOCIATED WITH RUPTURE AFTER ENDOVASCULAR ANEURYSM REPAIR (EVAR) OR OPEN REPAIR (OR) OF ABDOMINAL AORTIC ANEURYSM. BACKGROUND: GRAFT RUPTURE AFTER EVAR HAS BEEN REPORTED, OFTEN PRECEDED BY GRAFT-RELATED COMPLICATIONS. GRAFT RUPTURE HAS ALSO BEEN REPORTED AFTER OPEN REPAIR. METHODS: BY JULY 2009, A TOTAL OF 848 ELECTIVE EVARS AND 594 ELECTIVE OPEN REPAIRS WERE PERFORMED IN THE UNITED KINGDOM EVAR TRIALS 1 AND 2. PTS WERE FOLLOWED UP FOR COMPLICATIONS, REINTERVENTIONS, AND RUPTURE. THE INCIDENCE OF RUPTURE WAS EXPLORED IN RELATION TO BASELINE ANATOMY AND SUBSEQUENT COMPLICATIONS IN A COX REGRESSION ANALYSIS. RESULTS: THERE WERE NO RUPTURES IN THE OPEN REPAIR PATIENTS. A TOTAL OF 27 RUPTURES OCCURRED AFTER EVAR DURING A MEAN FOLLOW-UP OF 4.8 YEARS: CRUDE RATE = 0.7 [95% CONFIDENCE INTERVAL (CI): 0.5-1.0] RUPTURES PER 100 PERSON-YEARS. EIGHTEEN PTS (67%) DIED WITHIN 30 DAYS OF RUPTURE. FIVE RUPTURES OCCURRED IN THE 30 POSTOPERATIVE DAYS AND 22 AFTER THAT: CRUDE RATES OF RUPTURE = 7.2 (95% CI: 3.017.4) AND 0.6 (95% CI: 0.4-0.9) PER 100 PERSON-YEARS, RESPECTIVELY. PREVIOUS COMPLICATIONS (ENDOLEAK TYPE 1, TYPE 2 WITH SAC EXPANSION, TYPE 3, MIGRATION OR KINKING) INCREASED THE RISK OF RUPTURE, ADJUSTED HAZARD RATIO 8.83 (95% CI 3.7620.76), P<0.0001. CONCLUSIONS: THERE WERE NO RUPTURES AFTER OPEN REPAIR AND A LOW RATE AFTER EVAR, MORTALITY AFTER GRAFT RUPTURE IS HIGH AND PREVIOUS SERIOUS COMPLICATIONS ARE SIGNIFICANTLY ASSOCIATED WITH THE RISK OF RUPTURE. FEW RUPTURES AFTER EVAR SEEM TO BE SPONTANEOUS WITHOUT COMPLICATIONS IDENTIFIED DURING OPTIMAL SURVEILLANCE. THERE WAS NO SUGGESTION OF A SIGNIFICANT DIFFERENCE IN RUPTURE RATES BETWEEN GRAFT MANUFACTURES (NUMBER OF RUPTURES/PTS, CRUDE RATE PER 100 PERSON-YEARS). COOK/ZENITH: 11/469, 0.5; MEDTRONIC/TALENT: 13/250, 1.1; GORE/EXCLUDER 2/51, 0.7; OTHER 1/70, 0.3, 0/8 GRAFT UNK. THERE WERE NO RUPTURES IN THE 594 PTS HAVING OPEN REPAIR DURING AN AVERAGE FOLLOW-UP OF 5.3 YEARS. COMBINING 624 PTS RECEIVING ENDOVASCULAR REPAIR IN EVAR TRIAL 1 AND 224 PTS RECEIVING ENDOVASCULAR REPAIR IN EVAR TRIAL 2 YIELDED A TOTAL OF 848 REPAIRS, WHICH WERE FOLLOWED UP FOR AN AVERAGE OF 4.8 YEARS. DURING THIS TIME, A TOTAL OF 27 RUPTURES OCCURRED: 25 IN EVAR TRIAL 1 AND 2 IN EVAR TRIAL 2; CRUDE RATES OF RUPTURE = 0.8 (95% CI: 0.5-1) AND 0.2 (95% CI: 0.1-1.0) RUPTURES PER 100 PERSON YEARS, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT BIFURCATED STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death