BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT

    MDR report key: 1814080 · Received August 18, 2010

    Report

    Report Number
    2953200-2010-01575
    Event Type
    Injury
    Date Received
    August 18, 2010
    Report Date
    July 20, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK, PARALYSIS CVA, AND MIGRATION. PATIENT CODE: CVA/STROKE, RUPTURED ANEURYSM PRIOR TO STENT GRAFT PLACEMENT. IT IS UNKNOWN WHICH MANUFACTURERS' DEVICE CONTRIBUTED TO WHICH EVENT. NONE OF THE EVENTS IN THE ARTICLE MATCH EVENT INFORMATION ALREADY KNOWN TO MEDTRONIC. THE PHYSICIAN WAS CONTACTED AND REQUESTED TO PROVIDE SPECIFIC INFORMATION RELATED TO EACH EVENT RELATED TO TALENT DEVICES, SUCH AS THE LOT NUMBER, IMPLANT DATE, INTERVENTION AND PATIENT OUTCOME.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: ENDOVASCULAR REPAIR OF AORTIC ARCH LESIONS IN HIGH-RISK PATIENTS OR AFTER PREVIOUS AORTIC SURGERY: MIDTERM RESULTS. (J THORAC CARDIOVASC SURG 2010; 140:52-8). METHODS: FROM (B)(6) 1998 TO (B)(6) 2008, 57 THORACIC STENT GRAFTS WERE IMPLANTED IN 44 PATIENTS (SEX RATIO, 4.5; MEAN AGE, (B)(6) YEARS) FOR AORTIC ARCH REPAIR (ZONE 0 TO 2 ACCORDING TO THE ARCH MAP PROPOSED BY (B)(6)) OF 19 DEGENERATIVE ANEURYSMS. TWELVE TRAUMATIC TRANSECTIONS OF THE AORTA, 8 COMPLICATED AORTIC DISSECTIONS, 4 POSTCOARCTECTOMY AORTIC PSEUDOANEURYSMS, AND 1 PENETRATING ATHEROMATOUS ULCER. OF THE 44 PATIENTS 2 WERE IMPLANTED WITH TALENT THORACIC STENT GRAFT AND 9 WERE IMPLANTED WITH VALIANT STENT GRAFTS ALL PATIENTS WERE CONSIDERED TO BE AT HIGH SURGICAL RISK OWING TO SERIOUS COMORBIDITIES ((B)(6)) OR PREVIOUS AORTIC SURGERY. ENDOVASCULAR REPAIR WAS PERFORMED IN AN EMERGENCY SETTING 27.3% (N=12) OF THE PATIENTS. THIRTY-FOUR UNDERWENT A HYBRID TECHNIQUE WITH SUPRA-AORTIC DEBRANCHING AND SIMULTANEOUS OR STAGED ENDOVASCULAR STENT GRAFTING. DEBRANCHING WAS PERFORMED TO PROVIDE AN ADEQUATE PROXIMAL AORTIC LANDING ZONE, IN 28 PATIENTS BY A CERVICAL APPROACH AND IN 6 PATIENTS BY A STERNOTOMY APPROACH. RESULTS: THE TECHNICAL SUCCESS RATES FOR AORTIC ZONE 0 PATIENTS (N=6), ZONE 1 PATIENTS (N=4), AND ZONE 2 PATIENTS (N=34) WERE, RESPECTIVELY, 100%, 100% AND 97%. THE 30-DAY MORTALITY RATE WAS 20.4%. THE ACTUARIAL SURVIVAL WAS 70% OVER A MEAN FOLLOW-UP OF 29.9 MONTHS. THE RATE OF STROKE WAS 6.8% TWO (4.5%) CASES OF PARAPLEGIA WERE OBSERVED, 1 OF WHICH WAS REVERSIBLE AFTER CEREBROSPINAL FLUID DRAINAGE. THE RATE OF ENDOLEAK WAS 15.9% (N=7): 3 TYPE I, 3 TYPE II, AND TYPE III. THERE WERE NO CASES OF DEVICE MIGRATION, BUT 1 STENT-GRAFT COLLAPSE OCCURRED 20 DAYS AFTER EXCLUSION OF AN AORTIC TRAUMATIC TRANSECTION. CONCLUSION: HYBRID ENDOVASCULAR AORTIC ARCH RECONSTRUCTIONS, ALTHOUGH SOME OF THESE ADJUNCTIVE PROCEDURES REMAIN MAJOR OPERATIONS. PROVIDE ATTRACTIVE ALTERNATIVES FOR TREATING AORTIC ARCH LESIONS IN HIGH-RISK PATIENTS WHO WOULD OTHERWISE BE UNSUITABLE FOR OPEN REPAIR, WITH ACCEPTABLE PRIMARY RESULTS AND ENCOURAGING MIDTERM EFFICACY TO PREVENT RUPTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention