BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 4103248 · Received September 19, 2014

    Report

    Report Number
    2953200-2014-01880
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    January 1, 1998
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE: WHEN NOT TO IMPLANT THE MULTILAYER FLOW MODULATOR: LESSONS LEARNED FROM APPLICATION OUTSIDE THE INDICATIONS FOR USE IN PATIENTS WITH THORACOABDOMINAL PATHOLOGIES. SHERIF SULTAN,MCH, MD, NIAMH HYNES ,MD, MOHAMED SULTAN. J ENDOVASC THER. 2014;21:96-712. A (B)(6) WOMAN WITH A PREVIOUS TALENT STENT-GRAFT IN THE 34-MM-DIAMETER DESCENDING AORTA PRESENTED WITH A 76-MM TAAA. A SMALL 35-MM-DIAMETER MFM, (MULTILAYER FLOW MODULATOR )WHICH WAS UNDERSIZED WITH RESPECT TO THE AORTIC DIAMETER, WAS LANDED IN THE 40-MM TALENT GRAFT, RESULTING IN FAILURE MODE I, EXPANSION, AND RUPTURE. NO FURTHER INFORMATION IS AVAILABLE FOR THIS CASE. PURPOSE: TO SCRUTINIZE REGISTRY DATA ON THORACOABDOMINAL REPAIRS PERFORMED USING THE MULTILAYER FLOW MODULATOR (MFM) OUTSIDE THE INDICATIONS FOR USE (IFU) AND ANALYZE THE ADVERSE OUTCOMES. METHODS: OF 380 PATIENTS FROM EUROPE REGISTERED IN THE MFM GLOBAL REGISTRY AFTER TREATMENT FOR THORACOABDOMINAL AORTIC ANEURYSM (TAAA) OR DISSECTION, 38 (10%) PATIENTS (30 MEN; MEDIAN AGE 71 YEARS, RANGE 3Q-91) TREATED ON A COMPASSIONATE BASIS OUTSIDE THE IFU WERE ANALYZED. THIRTEEN PATIENTS HAD CHRONIC STANFORD TYPE 8 DISSECTION WITH ANEURYSMAL DILATATION > 6 CM. THERE WERE 6 MYCOTIC AND 4 SACCULAR ANEURYSMS IN ADDITION TO 15 PRIMARY TAAAS. THE MEAN ANEURYSM DIAMETER WAS 7.1 EM. TEN PATIENTS PRESENTED WITH RUPTURE, AND 23 PATIENTS HAD PREVIOUS OPEN OR THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). RESULTS: ALTHOUGH NO DEATH, PARAPLEGIA, STROKE, OR RENOVISCERAL COMPROMISE WAS DOCUMENTED DURING THE INITIAL HOSPITAL STAY, TECHNICAL SUCCESS WAS ZERO. THERE WERE 31 (81.6%) CASES IN WHICH THERE WAS FAILURE TO LAND THE DEVICE IN NORMAL AORTA. OTHER VIOLATIONS OF THE IFU INCLUDED 12 WITH INADEQUATE STENT OVERLAP AND 11 CASES INVOLVING A SMALL MFM BEING DEPLOYED INSIDE A LARGER ONE. FIVE OF THE 9 CASES IN WHICH AN UNDERSIZED DEVICE WAS USED RESULTED IN A TYPE I ENDOLEAK (FAILURE MODE 1). DURING A MEAN FOLLOW-UP OF 10.0:T6.9 MONTHS, ALL-CAUSE MORTALITY WAS 89.5% (34/38), OF WHICH 27 (71.1%) WERE ANEURYSM-RELATED DEATHS. OVERALL SURVIVAL, FREEDOM FROM ANEURYSM-RELATED DEATH, AND RUPTURE-FREE SURVIVAL ESTIMATES WERE 17.5%, 25.0%, 31.5%, RESPECTIVELY, AT 18 MONTHS. THERE WERE 8 VISCERAL BRANCH COMPLICATIONS; IN ALL, 14 SECONDARY ENDOVASCULAR INTERVENTIONS WERE REQUIRED IN 11 PATIENTS FOR ENDOLEAK (FAILURE MODES I AND II) OR STENT FORESHORTENING. NO FALSE LUMEN WAS COMPLETELY THROMBOSED IN THE DISSECTING ANEURYSMS. ALL ANEURYSMS SHOWED A MEAN SAC GROWTH RATE OF 0.12:T0.16 EM/MONTH. FACTORS HAVING A SIGNIFICANCE INFLUENCE ON RISK OF ANEURYSM-RELATED DEATH INCLUDED MAXIMUM ANEURYSM DIAMETER (P={L.025, HR 1.37, 95% CL 1.04 TO1.82), PREVIOUS TEVAR (P=(L.03, HR 2.44, 95% CL 1.10 TO 2.08), AND INADEQUATE OVERLAP BETWEEN MFM DEVICES (P<(><<)> 0.002, HR 4.02, 95% CL 1.70 TO 9.49). CONCLUSION: THERE ARE CLINICAL SCENARIOS IN WHICH THE MFM DOES NOT PERFORM WELL. THE MFM IS NOT A SOLUTION FOR PATIENTS LIVING ON BORROWED TIME AND SHOULD NOT BE USED INDISCRIMINATELY IN PATIENTS IN WHOM OTHER MODALITIES OF AORTIC REPAIR ARE NOT FEASIBLE. ITS USE MUST ADHERE TO THE IFU, AND ROBUST CLINICAL DATA ARE REQUIRED BEFORE CONSTRUCTING A RANDOMIZED CONTROLLED TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582530 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention