BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2950865 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00213
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK, STENT GRAFT OCCLUSION, MI. ANGULATED, IRREGULARLY SHAPED, CONICALLY SHAPED, SHORT AORTIC NECKS, TYPE II ENDOLEAK. CONCLUSION: ANGULATED, IRREGULARLY SHAPED, CONICALLY SHAPED, SHORT AORTIC NECKS, TYPE II ENDOLEAK.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: PRIMARY ENDOANCHORING IN THE ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS WITH AN UNFAVORABLE NECK; J ENDOVASC THER 2012;19:707-715. PURPOSE: TO INVESTIGATE THE FEASIBILITY AND EARLY RESULTS OF ENDOANCHORING (ENDOSTAPLING) USING A NEW COMMERCIALLY AVAILABLE DEVICE AS AN ADJUNCTIVE PROCEDURE DURING ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF ABDOMINAL AORTIC ANEURYSMS (AAAS) WITH AN UNFAVORABLE PROXIMAL NECK. METHODS: BETWEEN JUNE 2010 AND MAY 2012, 13 CONSECUTIVE PATIENTS (ALL MEN; MEDIAN AGE (B)(6), RANGE (B)(6)) WERE PROSPECTIVELY ENROLLED IN A 2-CENTER REGISTRY TO FOLLOW OUTCOMES OF ADJUNCTIVE PRIMARY ENDOANCHORING(APTUS HELIFX AORTIC SECUREMENT SYSTEM) OF THE PROXIMAL ENDOGRAFT TO ENHANCE PROXIMAL GRAFT FIXATION AND SEALING DURING EVAR. INDICATIONS FOR PROXIMAL NECK ENDOANCHORING INCLUDED AT LEAST ONE OF THE FOLLOWING: NECK ANGULATION 458 TO 908, LENGTH 8 TO 15 MM, DIAMETER 29 TO 33 MM, CONICAL NECK CONFIGURATION, OR AN IRREGULARLY SHAPED NECK. THE MEDIAN AAA DIAMETER WAS 56 MM (RANGE 50-98). THE ENDURANT STENT-GRAFT WAS IMPLANTED IN 4 PATIENTS AND THE ZENITH DEVICE IN 9. RESULTS: A MEDIAN OF 4 ENDOANCHORS WERE IMPLANTED PER PATIENT (RANGE 3-10) IN ADJUNCTIVE PROCEDURES THAT REQUIRED A MEDIAN 12 MINUTES (RANGE 7-20). INTRAOPERATIVELY, 2 PROXIMAL TYPE I ENDOLEAKS WERE PRESENT FOLLOWING ENDOANCHOR IMPLANTATION (85% PRIMARY TECHNICAL SUCCESS); A CUFF WAS DEPLOYED IN 1 CASE, WHICH SUCCESSFULLY SEALED THE ENDOLEAK (92% ASSISTED PRIMARY TECHNICAL SUCCESS). THE SECOND PROXIMAL TYPE I ENDOLEAK WAS MINUTE AND SEALED SPONTANEOUSLY WITHIN 30 DAYS. NO FURTHER MAJOR DEVICE-RELATED COMPLICATIONS OCCURRED INTRAOPERATIVELY. IN THE 30-DAY PERIOPERATIVE PERIOD, THE ONLY PROCEDURE-RELATED COMPLICATIONS WERE 2 TYPE II ENDOLEAKS, WHICH REQUIRED NO INTERVENTION. OVER A MEDIAN FOLLOW-UP OF 7 MONTHS (RANGE 2-17), NO FURTHER COMPLICATIONS OCCURRED APART FROM AN ASYMPTOMATIC INTERNAL ILIAC ARTERY OCCLUSION AND A NON-LETHAL MYOCARDIAL INFARCTION AT 9 MONTHS. THE TYPE II ENDOLEAKS SPONTANEOUSLY SEALED. NO ENDOGRAFT MIGRATION WAS NOTICED NOR LOSS OF ENDOANCHOR INTEGRITY. NO DEATHS OCCURRED THROUGHOUT FOLLOW-UP. CONCLUSION: PRIMARY ENDOANCHORING USING THE HELIFX AORTIC SECUREMENT SYSTEM IS FEASIBLE, AND EARLY RESULTS WERE PROMISING IN THIS SERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54532 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR