BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 3845288 · Received June 3, 2014

    Report

    Report Number
    2953200-2014-01098
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    August 18, 2013
    Report Date
    March 17, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. OPEN SURGICAL SECONDARY PROCEDURES AFTER THORACIC ENDOVASCULAR AORTIC REPAIR L. CANAUD, P. ALRIC, T. GANDET, B.A. OZDEMIR, B. ALBAT, C. MARTY-ANE HTTP://DX.DOI.ORG/10.1016/J.EJVS.2013.08 ON AN UNKNOWN DATE, A TALENT STENT GRAFT WAS IMPLANTED. ELEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED SECONDARY AO RTOBRONCHIAL FISTULAE. THE STENT GRAFT WAS REMOVED AND AN OPEN CONVERSION WAS PERFORMED. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVES: IMPROVED OUTCOMES OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) COMPARED WITH OPEN REPAIR HAVE CHANGED THE THERAPEUTIC PARADIGM OF THORACIC AORTIC LESIONS. AS THE NUMBER OF TEVAR SURVIVORS HAS GROWN, REPORTS OF COMPLICATIONS HAVE SIMILARLY INCREASED. ALTHOUGH SECONDARY ENDOVASCULAR RESCUE MEASURES ARE OFTEN UNDERTAKEN, PATIENTS WITH SERIOUS COMPLICATIONS ARE OFTEN CONVERTED, ULTIMATELY, TO OPEN REPAIR. THE AIM OF THIS STUDY WAS TO ASSESS CAUSES AND MIDTERM RESULTS OF OPEN SURGICAL SECONDARY PROCEDURES AFTER THORACIC ENDOVASCULAR AORTIC REPAIR. METHODS: A TOTAL OF 236 PATIENTS UNDERWENT TEVAR. FOURTEEN OF THESE PATIENTS REQUIRED OPEN REPAIR BECAUSE OF SIX AORTOBRONCHIAL FISTULAS, FOUR RETROGRADE TYPE A DISSECTIONS, TWO ANEURYSM ENLARGEMENT WITHOUT ENDOLEAK, ONE THORACIC STENT-GRAFT COLLAPSE, AND ONE AORTOESOPHAGEAL FISTULA. EIGHT (57.1%) PATIENTS UNDERWENT SURGICAL REPAIR USING CARDIOPULMONARY BYPASS. SIX STENT-GRAFTS WERE TOTALLY REMOVED, AND EIGHT STENT-GRAFTS WERE LEFT IN SITU. FOUR PATIENTS UNDERWENT SUPRACORONARY ASCENDING AORTA REPLACEMENT, AND ONE AN EXTENSIVE REPLACEMENT OF THE AORTIC ARCH THROUGH STERNOTOMY. THREE PATIENTS HAD DESCENDING AORTIC REPLACEMENT THROUGH LEFT THORACOTOMY COMBINED WITH A TOTAL ESOPHAGECTOMY IN ONE CASE. ONE PATIENT WAS TREATED BY LIGATION OF THE AORTIC ARCH, ASCENDING TO SUPRACELIAC ABDOMINAL AORTA BYPASS AND STENT-GRAFT EXPLANTATION. ONE PATIENT WAS TREATED BY EXCLUSION BYPASS OF THE DESCENDING THORACIC AORTA. PULMONARY RESECTION AND LARGE PLEURAL OR INTERCOSTAL MUSCLE FLAP INTERPOSITION TO WRAP THE STENT-GRAFT LEFT IN SITU WAS DONE IN FOUR CASES OF AORTOBRONCHIAL FISTULA. RESULTS: ALL PATIENTS SURVIVED THE SURGICAL PROCEDURE. TEN PATIENTS (71%) HAD AN UNEVENTFUL POSTOPERATIVE COURSE. THERE WERE TWO IN-HOSPITAL DEATHS (14.3%). BOTH DIED FROM MULTI-ORGAN FAILURE IN THE EARLY POSTOPERATIVE COURSE AFTER SURGICAL REPAIR OF A STENT-GRAFT INFECTION AND AN AORTOESOPHAGEAL FISTULA. ONE PATIENT SUFFERED A DEFINITIVE PARAPLEGIA AND A SECONDARY AORTOESOPHAGEAL FISTULA REQUIRING REOPERATION FOR ESOPHAGEAL REPAIR. ONE PATIENT, TREATED BY PULMONARY RESECTION AND FLAP INTERPOSITION TO WRAP THE STENT-GRAFT, UNDERWENT STENT-GRAFT EXPLANTATION AND IN SITU DESCENDING AORTIC REPLACEMENT BECAUSE OF STENT-GRAFT REINFECTION. ACTUARIAL SURVIVAL WAS 87.7% AFTER A MEAN FOLLOW-UP OF 26.3 MONTHS (RANGE 9E72 MONTHS). CONCLUSIONS: COMPLICATIONS OR PREVENTION OF COMPLICATIONS AFTER TEVAR EITHER DUE TO DEVICE FAILURE OR ADVERSE EVENTS MAY REQUIRE CONVERSION TO OPEN REPAIR OR ADDITIONAL OPEN SURGICAL PROCEDURE. OPEN REPAIR CAN BE PERFORMED BY A TEAM EXPERIENCED IN MANAGEMENT OF DISEASES OF THE THORACIC AORTA AND A LOW MORTALITY RATE ACHIEVED DESPITE THE PRECARIOUS PREOPERATIVE CONDITIONS AND COMPLEX AORTIC PATHOLOGIES OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325016 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention