BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 7266238 · Received February 13, 2018

    Report

    Report Number
    2953200-2018-00216
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    May 2, 2017
    Report Date
    February 13, 2018
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ANY NONADHERENCE TO INSTRUCTIONS FOR USE PREDICTS GRAFT-RELATED ADVERSE EVENTS IN PATIENTS UNDERGOING ELECTIVE ENDOVASCULAR ANEURYSM REPAIR. CHRISTINE R. HERMAN, MD, MSC, PHILIPPE CHARBONNEAU, MD, KIATTISAK HONGKU, MD, LUC DUBOIS, MD, MSC, SAJJID HOSSAIN, MD, KEVIN LEE, MD, AND OREN K. STEINMETZ, MD (JOURNAL OF VASCULAR SURGERY 2018;67:126-33.) JOURNAL OF VASCULAR SURGERY HERMAN ET AL 127 VOLUME 67, NUMBER 1 COPYRIGHT _ 2017 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTP://DX.DOI.ORG/10.1016/J.JVS.2017.05.095. FAILURE TO FOLLOW INSTUCTIONS - NECK (DIAMETER, LENGTH, ANGLE), ILIAC ARTERY (LENGTH, DIAMETER) IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TALENT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT GROUP FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING GRAFT RELATED ADVERSE EVENTS WERE OBSERVED: DEVICE LIMB OCCLUSION, SAC RUPTURE, ANEURYSM REPORTED IFU VIOLATIONS: NECK (DIAMETER, LENGTH, ANGLE), ILIAC ARTERY (LENGTH, DIAMETER). ABSTRACT BACKGROUND: A VARIETY OF DEVICES EXIST FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR). DEVICE-SPECIFIC INSTRUCTIONS FOR USE (IFU) DETAIL ANATOMIC CONSTRAINTS TO APPLICATION AND DEPLOYMENT OF DEVICES AND ARE DEVELOPED FROM RIGOROUS BENCH TESTING. NONADHERENCE TO IFU OCCURS FREQUENTLY TO AVOID OPEN SURGERY. THE PURPOSE OF THIS STUDY WAS TO DETERMINE IF IFU VIOLATIONS ARE ASSOCIATED WITH INCREASED RISK OF GRAFT-RELATED ADVERSE EVENTS (GRAES) DURING FOLLOW-UP. METHODS: THIS MULTICENTER RETROSPECTIVE OBSERVATIONAL STUDY INCLUDED PATIENTS UNDERGOING ELECTIVE ENDOVASCULAR REPAIR FOR ABDOMINAL ANEURYSMAL DISEASE WITH THREE DIFFERENT DEVICES. DEMOGRAPHICS, ANATOMIC DATA, AND FOLLOW-UP DATA WERE COLLECTED ON PATIENTS FROM 2005 TO 2014. IFU VIOLATIONS WERE DEVICE SPECIFIC AND INCLUDED NECK DIAMETER, LENGTH, AND ANGULATION AND ILIAC ARTERY DIAMETER AND LENGTH. GRAES INCLUDED A COMPOSITE OUTCOME OF REINTERVENTION, MIGRATION, ENDOLEAK (TYPE II EXCLUDED), RUPTURE, LIMB OCCLUSION, SAC GROWTH, AND ANEURYSM-RELATED MORTALITY DURING THE FOLLOW-UP PERIOD. KAPLAN-MEIER SURVIVAL AND COX PROPORTIONAL HAZARDS MODELING WERE PERFORMED. ANY IFU VIOLATIONS AS WELL AS NECK-SPECIFIC IFU VIOLATIONS WERE ANALYZED. RESULTS: IN 461 PATIENTS UNDERGOING EVAR, 43.8% HAD AT LEAST ONE IFU VIOLATION. PATIENTS WITH IFU VIOLATIONS WERE MORE LIKELY TO HAVE PERIPHERAL VASCULAR DISEASE (12.4% VS 7.3%) AND WERE LESS LIKELY TO BE MALE (78.7% VS 90.3%). THE MOST FREQUENT IFU VIOLATIONS INCLUDED DIAMETER DEVIATIONS OF THE NECK (15.2%) AND OF THE ILIAC ARTERY (21.4%). OVERALL, THE GRAE RATE WAS 12.8%. MEDIAN FOLLOW-UP TIME WAS 1.9 AND 2.1 YEARS FOR PATIENTS WITH AND WITHOUT AN IFU VIOLATION, RESPECTIVELY. KAPLAN-MEIER SURVIVAL REVEALED A SIGNIFICANT ASSOCIATION BETWEEN THE PRESENCE OF AN IFU VIOLATION AND GRAES (LOG-RANK, P ¼ .031). WHEN ADJUSTED FOR CLINICAL VARIABLE THROUGH COX HAZARD MODELING, THE ASSOCIATION REMAINED SIGNIFICANT (HAZARD RATIO 1.8; 95% CONFIDENCE INTERVAL, 1.05-3.1). WHEN NECK-SPECIFIC VIOLATIONS WERE CONSIDERED INDEPENDENTLY, KAPLAN-MEIER SURVIVAL (LOG-RANK, P ¼ .003) AND COX MODELING (HAZARD RATIO, 2.2; 95% CONFIDENCE INTERVAL, 1.2-4.0) RE VEALED A SIGNIFICANT ASSOCIATION BETWEEN NECK-SPECIFIC IFU VIOLATION AND GRAES. CONCLUSIONS: A TOTAL OF 43.8% OF PATIENTS UNDERGOING EVAR HAD A DEVICE-SPECIFIC IFU VIOLATION, INDICATING THAT IMPLANTERS ARE PUSHING THE BOUNDARIES OF DEVICE CAPABILITIES. OUR STUDY IDENTIFIED THAT ANY IFU VIOLATION WAS SIGNIFICANTLY ASSOCIATED WITH GRAES OVER TIME. CAUTION SHOULD BE APPLIED TO PATIENTS BEING CONSIDERED FOR EVAR WHEN IFU DEVIATIONS EXIST

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109521 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention