BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 2250024 · Received September 15, 2011

    Report

    Report Number
    2015691-2011-16176
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THIS DEVICE WAS EXPLANTED DUE TO MITRAL STENOSIS. IT HAS BEEN CONFIRMED BY THE SALES REP THAT THIS DEVICE WAS EXPLANTED DUE TO MITRAL REGURGITATION. THERE ARE MANY FACTORS THAT COULD RESULT IN THE NEED TO EXPLANT AN ANNULOPLASTY RING AND REPLACE WITH A BIOPROSTHETIC VALVE, THE MOST COMMON OF WHICH IS REGURGITATION. THESE COMPLICATIONS CAN HAVE MANY ROOT CAUSES, INCLUDING BUT NOT LIMITED TO PATIENT FACTORS, (AGE, DISEASE STATES, COMORBIDITIES), PHARMACOLOGICAL FACTORS, PROCEDURE FACTORS . IT IS TYPICALLY NOT RELATED TO PRODUCT MALFUNCTION. IN THIS CASE, REPLACEMENT OF THE NATIVE HEART VALVE WAS DUE TO REGURGITATION AND THE EXPLANT WAS NOT RELATED TO PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED THE RING EXHIBITS MODERATE TO HEAVY HOST TISSUE OVERGROWTH. SUTURE THREADS ARE EVIDENT IN THE SEWING RING. NO INCONSISTENCIES DETECTED IN THE X-RAY, AS THE RIN IS INTACT. THE RETURNED DEVICE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE (ASSET # (B)(4)), DIGITAL MICROSCOPE (ASSET# (B)(4)). THE X-RAY USED MET ID# (B)(4). METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS. STENOSIS CAN BE DUE TO MANY FACTORS DEPENDING ON THE IMPLANT DURATION AND INCLUDES BUT IS NOT LIMITED TO CALCIFICATION AND PANNUS. IN THIS CASE, THE EVALUATION OBSERVED HOST TISSUE OVERGROWTH (PANNUS) WHICH MAY HAVE LED TO THE REPORTED STENOSIS. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH AN IMPLANTED DEVICE. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE - BOTH NATIVE AND BIOPROSTHETIC. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. SINCE THE MECHANISM OF HOST TISSUE GROWTH IS STILL NOT FULLY UNDERSTOOD, AND THERE IS LIMITED INFORMATION PROVIDED WITH REGARD TO THE PATIENT'S HISTORY, THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    REPORTEDLY, A 26MM ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS, 8 MONTHS (80.03 MONTHS) DUE TO MITRAL STENOSIS. THE CUSTOMER REPORTED THAT A COSGROVE (B)(4) WAS IMPLANTED FOR MITRAL VALVULOPLASTY (MVP) TO CORRECT MITRAL REGURGITATION (MR) ON (B)(6) 2004. SOME YEARS LATER, MITRAL STENOSIS (MR) WAS OBSERVED. ON (B)(6) 2011, THE RING WAS EXPLANTED AND A 25MM VALVE WAS IMPLANTED AS A REPLACEMENT. TRICUSPID ANNULOPLASTY (TAP) WITH A COSGROVE (B)(4) RING WAS ALSO PERFORMED. CUSTOMER COMMENTED THAT THIS EXPLANT WAS NOT EXPECTED BUT NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 03L096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R