BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 12520511 · Received September 23, 2021

    Report

    Report Number
    2210968-2021-08800
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    October 1, 2020
    Report Date
    September 3, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE DEATH OF THE PATIENT DUE TO INFECTIVE ENDOCARDITIS WITH CEREBRAL HEMORRHAGE AND EMBOLISM AFTER EXTERNAL SUTURE ANNULOPLASTY? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO NON-DEATH CASES WITH POST-OP COMPLICATIONS (AORTIC REGURGITATION, AORTIC STENOSIS, SUBAORTIC STENOSIS, INFECTIVE ENDOCARDITIS, AORTIC ROOT DILATATION, UNKNOWN CAUSE) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ETHIBOND SUTURE) USED FOR ALL CASES IN THIS STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR DEATH CASE AND NON-DEATH CASES WITH POST-OP COMPLICATIONS (AORTIC REGURGITATION, AORTIC STENOSIS, SUBAORTIC STENOSIS, INFECTIVE ENDOCARDITIS, AORTIC ROOT DILATATION, UNKNOWN CAUSE)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. WOULD THE AUTHOR/SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCTS INVOLVED IN THE DEATH CASE? HAS AN AUTOPSY BEEN PERFORMED FOR DEATH CASE WITH EMBOLISM AND CEREBRAL HEMORRHAGE DUE TO INFECTIVE ENDOCARDITIS? IF SO, CAN THE RESULTS BE SHARED? CITATION: EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY (2021); 59:253¿261. DOI:10.1093/EJCTS/EZAA285. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS WERE SUBMITTED VIA 2210968-2021-08799.

    Description of Event or Problem · 1

    TITLE: UNICUSPID AORTIC VALVE REPAIR WITH BICUSPIDIZATION IN THE PAEDIATRIC POPULATION THIS RETROSPECTIVE STUDY IS TO REVIEW THE AUTHOR'S EXPERIENCE WITH THESE PROCEDURES FOR UNICUSPID AORTIC VALVE (UAV) REPAIR IN THE PAEDIATRIC POPULATION TO ANALYSE THE MID- TO LONG-TERM DURABILITY OF THIS APPROACH. BETWEEN 2003 AND 2018, A TOTAL OF 60 PATIENTS [49 WERE MALES; MEDIAN AGE OF 13 (1¿18) YEARS] WITH A UNICUSPID AORTIC VALVE (UAV) WHO UNDERWENT BICUSPIDIZATION WERE INCLUDED IN THE STUDY. SINCE 2009, AN EXTERNAL SUTURE ANNULOPLASTY WAS PERFORMED BEFORE CUSP REPAIR IN PATIENTS WITH A BASAL RING DIAMETER OF >26MM. INITIALLY, A BRAIDED POLYESTER SUTURE (ETHIBOND 2; ETHICON, HAMBURG, GERMANY) WAS USED. SINCE 2010, AN EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) SUTURE (COMPETITOR) WAS EMPLOYED. CUSP REPAIR WAS PERFORMED USING DEVICES FROM COMPETITORS. REPORTED COMPLICATIONS INCLUDE (N=?) AORTIC REGURGITATION AND (N=?) AORTIC STENOSIS REQUIRING REOPERATION; (N=?) SUBAORTIC STENOSIS, (N=?) INFECTIVE ENDOCARDITIS, (N=?) AORTIC ROOT DILATATION, (N=?) UNKNOWN CAUSE REQUIRING AORTIC VALVE REOPERATION. IN CONCLUSION, BICUSPIDIZATION IS A SAFE AND REPRODUCIBLE ALTERNATIVE TO VALVE REPLACEMENT WITH ACCEPTABLE FREEDOM FROM REOPERATION. IT CAN SERVE AS A BRIDGE TO VALVE REPLACEMENT PROVIDING SUPERIOR OUTCOMES IN ADULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415781 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention