BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND 620BG23 DURAN ANCORE ANNULOPLASTY C

    MDR report key: 4606523 · Received March 16, 2015

    Report

    Report Number
    2025587-2015-00321
    Event Type
    Injury
    Date Received
    March 16, 2015
    Date of Event
    February 18, 2015
    Report Date
    April 10, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K960356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE NOT RETURNED TO MEDTRONIC. (B)(4). TITLE: LONG-TERM OUTCOMES OF MITRAL VALVE REPAIR WITH THE DURAN FLEXIBLE RING AUTHORS: HIDEO KANEMITSU, M.D., YUKIKATSU OKADA, M.D., YOSHITO SAKON, M.D.,YASUNOBU KONISHI, M.D., KEN NAKAMURA, M.D., NAOTO FUKUNAGA, M.D., YOSHIAKI SAJI, M.D., AND TADAAKI KOYAMA, M.D. JOURNAL: JOURNAL OF CARDIAC SURGERY 2015;XX:1¿5 DOI: 10.1111/JOCS.12522.

    Additional Manufacturer Narrative · 1

    CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION(S). WITHOUT PRODUCT SERIAL NUMBER(S) NO DEVICE HISTORY RECORDS COULD BE PULLED FOR REVIEW.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A RETROSPECTIVE STUDY WAS PERFORMED TO EXAMINE THE LONG-TERM RESULTS FOLLOWING MITRAL VALVE REPAIR WITH IMPLANTATION OF AN ANNULOPLASTY FLEXIBLE RING. THE STUDY ASSESSED 226 PATIENTS WHO UNDERWENT MITRAL VALVE REPAIR FOR SIGNIFICANT MITRAL REGURGITATION BETWEEN SEPTEMBER 1994 AND MARCH 2003. THE PATIENT POPULATION WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 56.7 YEARS. OVER A MEAN FOLLOW-UP OF 10.6 YEARS, THERE WERE A TOTAL OF THREE EARLY DEATHS AND 25 LATE DEATHS. THE THREE EARLY DEATHS OCCURRED AT THE HOSPITAL, AND WERE CAUSED BY LOW OUTPUT SYNDROME (N=2) AND ISCHEMIC COLITIS (N=1). OF THE 25 LATE DEATHS, 11 DEATHS WERE CLASSIFIED AS NON-CARDIAC CAUSES (CARCINOMA (N=7), PNEUMONIA (N=3), AND RENAL FAILURE (N=1)), 11 DEATHS WERE CLASSIFIED AS CARDIAC CAUSES (ARRHYTHMIA (N=1), MYOCARDIAL INFARCTION (N=1), CEREBRAL INFARCTION (N=5), AND CEREBRAL BLEEDING (N=4)), AND THREE DEATHS WERE OF UNKNOWN CAUSES. DURING THE STUDY THERE WERE EIGHT REOPERATIONS FOR MITRAL VALVE REPLACEMENT DUE TO: MITRAL REGURGITATION RECURRENCE CAUSED BY RECURRENT LEAFLET PROLAPSE (N=2) AND LEAFLET SCLEROSIS (N=1), HEMOLYSIS CAUSED BY RESIDUAL MITRAL REGURGITATION (N=1) AND LEAFLET PROLAPSE (N=1), MITRAL STENOSIS DUE TO LEAFLET CALCIFICATION (N=1), INFECTIVE ENDOCARDITIS (N=1), AND AN UNKNOWN CAUSE (N=1). OF THE EIGHT REOPERATIONS, FIVE VALVES WERE REPAIRED, AND THREE WERE REPLACED. OTHER ADVERSE EVENTS INCLUDED 27 THROMBOEMBOLIC COMPLICATIONS (FIVE OF WHICH RESULTED IN FATALISTIC STROKES, AND 15 OF WHICH HAD ATRIAL FIBRILLATION TREATED MEDICINALLY), AND 19 RECURRENCES OF SIGNIFICANT MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177314 BAND 620BG23 DURAN ANCORE ANNULOPLASTY C RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620BG23

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Life Threatening| R