BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2160631 · Received July 6, 2011

    Report

    Report Number
    2953200-2011-01240
    Event Type
    Injury
    Date Received
    July 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK. LOT NUMBER, IMPLANT DATE, ANATOMY, ETC. NOT PROVIDED. CONCLUSION: LOT NUMBER, IMPLANT DATE, ANATOMY, CAUSE OF ENDOLEAK, ETC. NOT PROVIDED. THE PHYSICIAN WAS CONTACTED AND REQUESTED TO PROVIDE SPECIFIC INFORMATION RELATED TO THIS EVENT, SUCH AS THE LOT NUMBER AND IMPLANT DATE. THIS INFORMATION HAS NOT BEEN RECEIVED FROM THE PHYSICIAN. NO EVENTS IN THE ARTICLE MATCH EVENTS PREVIOUSLY REPORTED TO MEDTRONIC.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: SAFETY AND FEASIBILITY OF BALLOON-EXPANDABLE STENT IMPLANTATION FOR THE TREATMENT OF TYPE I ENDOLEAKS FOLLOWING ENDOVASCULAR AORTIC ABDOMINAL ANEURYSM REPAIR; EUROINTERVENTION 2011:6:740-743. PURPOSE: THE OCCURRENCE OF TYPE I ENDOLEAKS REPRESENTS AN OMINOUS SIGN AFTER ENDOVASCULAR ANEURYSMS REPAIR (EVAR) USING BALLOON-EXPANDABLE STENTS (BES) FOR THE TREATMENT OF PROXIMAL TYPE I ENDOLEAKS AT FIVE HIGH-VOLUME HOSPITALS IN ARGENTINA. METHODS: OF 1,395 PATIENTS WHO UNDERWENT EVAR, DATA WAS RETROSPECTIVELY COLLECTED OF 29 (2%) CONSECUTIVE PATIENTS WHO UNDERWENT ADDITIONAL BES TO REPAIR PROXIMAL TYPE I ENDOLEAKS. TWO CASES (N=2) INVOLVED MEDTRONIC DEVICES; THE OTHER CASES INVOLVED DEVICES FROM OTHER MANUFACTURERS. THE MEAN AGE WAS (B)(6) (RANGE (B)(6)) AND 93% WERE MALE. A HOSTILE ANATOMY WAS FOUND IN 89.6% OF THE CASES. BES OVERSIZE (BALLOON/NECK DIAMETER RATION L30%) WAS FREQUENT (69%); WHEREAS, BES/PROSTHESIS DIAMETER RATIO WAS LESS THAN 1 IN 79% OF THE CASES. COMPLETE AND PARTIAL SEALING WAS OBTAINED 72 AND 28% OF THE CASES, RESPECTIVELY. THERE WERE NO IMMEDIATE OR LATE SURGICAL CONVERSION OR MAJOR COMPLICATIONS RELATED WITH STENT IMPLANTATION. AT A MEDIAN TIME FOLLOW-UP OF 14.9 MONTHS (25-75% INTERQUARTILES: 4.5-17.5 MONTHS), THERE WERE NO CARDIOVASCULAR DEATHS, EVIDENCE OF ANEURYSM SAC ENLARGEMENT OR NEED FOR RE-INTERVENTION. THE PRELIMINARY RESULTS SUGGEST THAT BES IMPLANTATION FOR THE TREATMENT OF PROXIMAL TYPE I ENDOLEAKS IS FEASIBLE AND SAFE WITH FAVORABLE MID-TERM RESULTS AND MAY PRECLUDE THE NEED FOR SURGICAL CONVERSION. FOR THE FIRST TALENT CASE, THE STENT GRAFT WAS IMPLANTED IN 2009; THE EVENT OCCURRED 1.5 YEARS POST IMPLANT (REF. MFR 2953200-2011-01239). THE LOT NUMBER IS UNKNOWN. FOR THE SECOND TALENT CASE, THE STENT GRAFT WAS IMPLANTED IN 2008; THE EVENT OCCURRED 5 MONTHS POST IMPLANT. THE LOT NUMBER IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT STATUS IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention