BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS

    MDR report key: 9322664 · Received November 14, 2019

    Report

    Report Number
    2015691-2019-04223
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    January 1, 2001
    Report Date
    October 23, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWQ
    PMA / PMN Number
    P870038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: BASED ON THE INFORMATION RECEIVED THE CAUSE WAS LIKELY DUE TO PATIENT FACTORS AND PROGRESSION OF UNDERLYING VALVULAR DISEASE PATHOLOGY.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: REPORTS OF PANNUS AND STENOSIS WERE CONFIRMED THROUGH IMAGE EVALUATION BASED ON PHOTOS INCLUDED IN ARTICLE ARTICLE. IMAGE OF ONE STARR-EDWARDS BALL VALVE WAS PROVIDED IN THE D IMAGE OF FIGURE 1. BALL VALVE APPEARED TO HAVE A RING OF HEAVY HOST TISSUE OVERGROWTH AROUND THE CIRCUMFERENCE. HOST TISSUE OVERGROWTH LED TO STENOSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION AND RETURN OF THE DEVICE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. HOST TISSUE 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. BASED ON THE INFORMATION RECEIVED THE CAUSE CANNOT BE DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CONTRIBUTED TO THE EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    ARTICLE "CLINICAL OUTCOMES OF REPEAT AORTIC VALVE REPLACEMENT FOR SUBAORTIC PANNUS IN MECHANICAL AORTIC VALVE," CIRC J. 2018; 82: 2535-2541 DOI:10.1253/CIRCJ.CJ-18-0352 BACKGROUND: THIS STUDY AIMED TO EVALUATE THE EARLY AND LATE CLINICAL OUTCOMES AFTER REPEAT AORTIC VALVE REPLACEMENT (AVR) FOR SUBAORTIC PANNUS IN PATIENTS WITH MECHANICAL VALVES. METHODS AND RESULTS: BETWEEN 2001 AND 2017, 51 PATIENTS (MEDIAN AGE, 59 YEARS; 42 WOMEN) WITH PROSTHETIC AORTIC STENOSIS (AS) CAUSED BY PANNUS INGROWTH UNDERWENT REPEAT AVR BECAUSE OF ACUTE MALFUNCTION OF MONOLEAFLET VALVE (3 PATIENTS), SEVERE PROSTHETIC AS (30 PATIENTS), AND MODERATE PROSTHETIC AS AT THE TIME OF TRICUSPID OR MITRAL VALVE SURGERY (18 PATIENTS). THE MEDIAN FOLLOW-UP DURATION WAS 100 (INTERQUARTILE RANGE, 64-138) MONTHS. DOUBLE VALVE REPLACEMENT WAS PERFORMED IN 45 (88%) PATIENTS. MEDIAN TIME INTERVAL FROM PREVIOUS OPERATION WAS 161 (INTERQUARTILE RANGE, 121-194) MONTHS. THE EXPLANTED MECHANICAL AV WAS MONOLEAFLET AND BILEAFLET IN 16 (31%) AND 34 (67%) PATIENTS, RESPECTIVELY. CONCOMITANT PROCEDURES INCLUDED 16 MITRAL VALVE REPLACEMENTS (14 REPEAT) AND 36 TRICUSPID VALVE SURGERIES (15 REPLACEMENTS, 21 REPAIRS). NO HOSPITAL DEATHS OR CASES OF HEART BLOCK OCCURRED. OVERALL SURVIVAL AND EVENT-FREE SURVIVAL RATES AT 10 YEARS WERE 88% AND 51%, RESPECTIVELY. LATE COMPLICATIONS INCLUDED RECURRENT PROSTHETIC AS (4 PATIENTS), NEW PARAVALVULAR LEAKAGE OF THE MITRAL VALVE (5 PATIENTS), AND SEVERE TRICUSPID REGURGITATION (2 PATIENTS). CONCLUSIONS: ALTHOUGH REPEAT AVR FOR SUBAORTIC PANNUS HAD ACCEPTABLE EARLY AND LATE SURVIVAL, RECURRENT PROSTHETIC AS WAS FREQUENTLY OBSERVED DURING LATE FOLLOW-UP. ONE (1) MECHANICAL VALVE MODEL 12608A (STARR-EDWARDS VALVE SIZED 21MM) IMPLANTED IN THE AORTIC POSITION WAS EXPLANTED DUE TO SUBAORTIC PANNUS LEADING TO AORTIC STENOSIS AFTER AN UNKNOWN EXACT IMPLANT DURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119346 STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS HEART-VALVE, MECHANICAL LWQ EDWARDS LIFESCIENCES 12608A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R