BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 8446814 · Received March 24, 2019

    Report

    Report Number
    2017865-2019-04334
    Event Type
    Injury
    Date Received
    March 24, 2019
    Report Date
    March 24, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES PRIMARY SOURCE ¿ ELSEVIER JOURNAL OF CARDIOLOGY - TRANSVENOUS EXTRACTION OF ADVISORY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS WITH A RELATIVELY LONG IMPLANT DURATION$ MASAHIKO GOYA (MD)A,*, MICHIO NAGASHIMA (MD)B, KEN-ICHI HIROSHIMA (MD)B, KENTARO HAYASHI (MD)B, YU MAKIHARA (MD)B, MASATO FUKUNAGA (MD)B, YOSHIMORI AN (MD)B, MASATSUGU OHE (MD)B, TAKESHI SASAKI (MD)A, SHINYA SHIOHIRA (MD)A, YASUHIRO SHIRAI (MD)A, MIHOKO KAWABATA (MD)A, KENJI ANDO (MD)B, MITSUAKI ISOBE (MD, FJCC)A, KENZO HIRAO (MD)A. GOYAL SK, ELLIS CR, ROTTMAN JN, WHALEN SP. LEAD THROMBI ASSOCIATED WITH EXTERNALIZED CABLES ON RIATA ICD LEADS: A CASE SERIES. J CARDIOVASC ELECTRO-PHYSIOL 2013;24:1047¿50. DEMIREL E, ADIYAMAN A, DELNOY PP, ELVAN A. EXTREME EXTERNALIZATION OF RIATA INTRACARDIAC CARDIOVERTER DEFIBRILLATOR LEADS: A NEW PERIL OF A TROUBLESOME LEAD. J CARDIOVASC ELECTROPHYSIOL 2014;25:216.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ELSEVIER JOURNAL OF CARDIOLOGY - JAPANESE COLLEGE OF CARDIOLOGY STUDY, THAT RIATA LEADS WERE EXTRACTED DUE TO LEAD INFECTION AND LEAD FAILURE. THE JOURNAL STUDIED EXTRACTION OF ICD LEADS AFTER LONG IMPLANTATION DURATION AND DETERMINED THIS COULD BE ACHIEVED SAFELY. NO FURTHER INFORMATION IS PROVIDED WITHIN THE ARTICLE. SPECIFIC PATIENT INFORMATION IS UNKNOWN. THE JOURNAL WAS PUBLISHED 25 APRIL 2018. IT WAS REPORTED BY THE JOURNAL THAT 28 PATIENTS: 19 MEDTRONIC FIDELIS, 8 RIATA ST. JUDE MEDICAL (ABBOTT) AND 1 ISOLINE LEAD WERE USED IN THE TRIAL. THE INDICATION FOR EXTRACTION WERE DEVICE INFECTIONS, LEAD FAILURES OR PROPHYLACTIC EXTRACTION. ELECTRICAL FAILURES WERE DEFINED AS HIGH PACING THRESHOLDS, LOW R WAVE SENSING, IMPEDANCE OUT OF NORMAL RANGE AND NON-PHYSIOLOGIC NOISE AS WELL AS PREVIOUS LEAD FAILURE. PATIENTS WITH EIGHT RIATA (ST JUDE MEDICAL/ABBOTT) LEADS WITH MODELS 1570/65 (2), 1571/65 (4), 1580/60 (1), 1580/65(1) WERE USED. RIATA EXTRACTION: ONE RIATA LEAD WAS EXTRACTED DUE INFECTION. THREE RIATA LEADS DUE TO LEAD FAILURE. FOUR WERE EXTRACTED FOR PROPHYLACTIC INDICATIONS OF BATTERY EXCHANGE. THE JOURNAL DID NOT SPECIFY THE SPECIFIC MODELS FOR EACH ISSUE. NO INAPPROPRIATE SHOCKS WERE NOTED. THE RIATA AND RIATA ST WERE PART OF A RECALL. THE STUDY REFERENCES A DIFFERENT STUDY OF 776 PATIENTS WITH RIATA/RIATA ST LEADS WHERE PATIENTS WERE FOLLOWED FOR 3 YEARS AND ELECTRICAL FAILURES WERE NOTED IN 5% OF LEADS WITH A CE MARK AS COMPARED TO 3 % WITHOUT A CE MARK. A DIFFERENCE NOT STATISTICALLY SIGNIFICANT. THE 8 FR MODEL WAS ASSOCIATED WITH A GREATER RISK OF FAILURES. CAREFUL MONITORING REMOTELY WAS RECOMMENDED FOR THE RIATA LEAD. REFERENCES TO OTHER ARTICLES INDICATING THROMBUS ADHERENCE TO EXTERNALIZED CONDUCTORS (A) AND EXTERNALIZATION OF CONDUCTORS REACHING THE PULMONARY ARTERY (B) WERE MENTIONED AS POINTS TO TAKE INTO CONSIDERATION DO DETERMINE MANAGEMENT STRATEGY FOR SOME RIATA LEADS. NO EXTRACTION WAS PERFORMED IN TWO RIATA ADVISORY PATIENTS BECAUSE BOTH HAD HIGH RISK FACTORS SUCH AS AGE AND LOW CARDIAC FUNCTION. ONE OF THESE PATIENTS HAD NO ELECTRICAL LEAD FAILURE WHILE THE OTHER HAD AN ELECTRICAL LEAD FAILURE BUT VENTRICULAR PACING WAS NOT REQUIRED. ALL ADVISORY ICD LEADS WERE EXTRACTED SUCCESSFULLY. A MAJOR COMPLICATION OCCURRED IN ONE PATIENT, BUT IT WAS NOT STATED WHETHER THIS WAS AN ABBOTT LEAD. THERE WERE NO OTHER MAJOR COMPLICATIONS AND NO DEATHS. THE DATA SUGGESTED ICD LEADS WITH LONG IMPLANT DURATIONS COULD BE EXTRACTED SAFELY ALTHOUGH A CASE BY CASE APPROACH WAS BEST. THERE IS A POSSIBILITY THESE DEVICES WERE PREVIOUSLY REPORTED INDIVIDUALLY BUT WITHOUT KNOWLEDGE OF THE PATIENT IDENTITY, SERIAL NUMBERS OR SPECIFIC MODELS WITH THE ISSUES STATED IN THIS CLINICAL TRIAL THE INFORMATION IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239785 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1580/60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention