BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 6400164 · Received March 13, 2017

    Report

    Report Number
    2953200-2017-00383
    Event Type
    Injury
    Date Received
    March 13, 2017
    Date of Event
    June 6, 2016
    Report Date
    February 16, 2017
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: RE-INTERVENTIONS AFTER ENDOVASCULAR AORTIC REPAIR FOR INFRARENAL ABDOMINAL ANEURYSMS: A RETROSPECTIVE COHORT STUDY. AUTHORS: HAKAN ROOS, HENRIK DJERF , LUDVIG BRISBY JEPPSSON , VICTORIA FROJD , TOMAS AXELSSON, ANDERS JEPPSSON, AND MARTEN FALKENBERG. ROOS ET AL. BMC CARDIOVASCULAR DISORDERS (2016) 16:124 DOI 10.1186/S12872-016-0309-0 AN ENDURANT AND TALENT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND RUPTURED AORTIC ANEURYSMS. THE FOLLOWING INFORMATION IS IN THIS JOURNAL ARTICLE: TYPE I ENDOLEAK, TYPE II ENDOLEAK, TYPE III ENDOLEAK; TYPE IV ENDOLEAK, STENT GRAFT MIGRATION; SURGICAL CONVERSION; THROMBOSIS; FEVER; INFECTION; ISCHEMIA; INACCURATE DELIVERY; BLOOD LOSS; OCCLUSION; LOSS OF SEAL. ABSTRACT BACKGROUND: EARLY MORBIDITY AND MORTALITY ARE GENERALLY LOWER AFTER ENDOVASCULAR AORTIC REPAIR (EVAR), THAN AFTER OPEN REPAIR BUT RE-INTERVENTIONS AND LATE COMPLICATIONS ARE MORE COMMON. THE AIM OF THE PRESENT STUDY WAS TO MAKE A DETAILED DESCRIPTION OF RE-INTERVENTIONS AFTER EVAR-INCLUDING INCIDENCE, INDICATIONS, PROCEDURES, AND OUTCOME-WITH SPECIAL REFERENCE TO NON-ACCESS-RELATED RE-INTERVENTIONS. METHODS: THIS IS A RETROSPECTIVE SINGLE-CENTER COHORT STUDY OF RE-INTERVENTIONS AFTER STANDARD EVAR WITH SPECIAL REFERENCE TO NON-ACCESS-RELATED RE-INTERVENTIONS. CONSECUTIVE PATIENTS (N = 405) TREATED WITH STANDARD EVAR FOR NON-RUPTURED (N = 337) OR RUPTURED (N = 68) INFRARENAL ANEURYSMS BETWEEN 2005 AND 2013 WERE ANALYSED. MEDIAN FOLLOW-UP WAS 29 MONTHS (RANGE 0¿108). RESULTS: EIGHTY-NINE PATIENTS (22 %) UNDERWENT 113 RE-INTERVENTIONS DURING FOLLOW-UP. TWENTY-SEVEN PATIENTS (7 %) HAD 28 ACCESS RELATED RE-INTERVENTION, 65 PATIENTS (16 %) HAD 85 NON-ACCESS RELATED REINTERVENTIONS. NON-ACCESS RELATED RE-INTERVENTIONS WERE MORE COMMON IN RUPTURED ANEURYSMS THAN IN UNRUPTURED ANEURYSMS (22 VS. 15 %, P = 0.002). THE MOST FREQUENT INDICATIONS WERE ENDOLEAK TYPE I (N = 19), TYPE II (N = 21), OR TYPE III (N = 5); STENT GRAFT MIGRATION (N = 9); AND THROMBOSIS (N = 14). THE MOST FREQUENT PROCEDURES WERE EMBOLIZATION OF ENDOLEAK TYPE II (N = 21), ADDITIONAL ILIAC STENT GRAFT (N = 19), PROXIMAL EXTENSION (N = 12), THROMBOLYSIS (N = 8), ILIAC LIMB BARE-METAL STENTING (N = 6), AND STENT GRAFT RELINING (N = 7). ENDOVASCULAR TECHNIQUE WAS USED IN 83 % OF RE-INTERVENTIONS. THIRTY-DAY MORTALITY AFTER NON-ACCESS-RELATED RE-INTERVENTIONS WAS 15 % WHEN INITIATED FROM SYMPTOMS (RUPTURE OR INFECTION) AND 0 % WHEN INITIATED FROM FOLLOW-UP FINDINGS (P = 0.014). CUMULATIVE SURVIVAL FIVE YEARS AFTER EVAR WAS 72 % IN PATIENTS WITH A RE-INTERVENTION AND 59 % IN PATIENTS WITHOUT (P = 0.21). CONCLUSIONS: NON-ACCESS-RELATED RE-INTERVENTION RATES ARE STILL CONSIDERABLE AFTER EVAR AND MORE FREQUENT AFTER RUPTURED ANEURYSMS. ENDOLEAK EMBOLIZATION IS THE MOST FREQUENT PROCEDURE, FOLLOWED BY ADDITIONAL ILIAC STENT GRAFTS. OUTCOMES AFTER RE-INTERVENTIONS ARE GENERALLY GOOD, EXCEPT WHEN INITIATED BY RUPTURE OR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181396 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention