BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUT.PROLENE AZ 6-0 75 CM C-1(2

    MDR report key: 18927446 · Received March 18, 2024

    Report

    Report Number
    2210968-2024-03159
    Event Type
    Death
    Date Received
    March 18, 2024
    Date of Event
    March 1, 2024
    Report Date
    May 6, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? NO.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THE NEEDLE PULL OFFS RELATED TO THE DEATH? DID THE SUTURES CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH? IF YES, WHAT IS THE ALLEGED DEFICIENCY OF THE SUTURES THAT LED TO THE DEATH? WHAT WAS THE CAUSE OF DEATH FOR THE PATIENT? ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE PATIENT'S WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE/SUTURE? WHERE WAS THE NEEDLE GRASPED DURING USE? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. RELATED MEDWATCH REPORTS: 2210968-2024-03155, 2210968-2024-03156, 2210968-2024-03157, 2210968-2024-03158, 2210968-2024-03160.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFTING + MITRAL VALVULOPLASTY + TRICUSPID VALVULOPLASTY IN HOSPITAL ON (B)(6) 2024 DUE TO PALPITATION, CHEST TIGHTNESS, SHORTNESS OF BREATH AND HEART FAILURE AND SUTURE WAS USED FOR SEWING THE BYPASS VESSEL IN A CONTINUOUS SUTURING MANNER. PULL OFF SUTURE NEEDLE ISSUE OCCURRED DURING THE SURGERY. THE DETACHED NEEDLE WAS REMOVED FROM THE PATIENT. THE SURGEON IMMEDIATELY REPLACED A NEW SUTURE PRODUCT TO CONTINUE THE SEWING. THE SUBSEQUENT SURGERY WENT SMOOTHLY. LATER, THE PATIENT'S HEART COULD NOT REBOUND, AND THE SURGEON IMMEDIATELY PERFORMED RESCUE. THE PATIENT DIED ON (B)(6) 2024. AFTER CONTACTING THE HOSPITAL, THE HOSPITAL FEEDBACK THAT THE PATIENT HAD POOR HEART, POOR PHYSICAL FITNESS, POOR CARDIAC FUNCTION AND VASCULAR STENOSIS. THE PHYSICIAN CONSIDERED THAT THE CAUSE OF DEATH WAS PATIENT'S PHYSICAL CONDITION (71-YEAR-OLD PATIENT WITH POOR CARDIOPULMONARY FUNCTION), NOT RELATED TO OUR SUTURE PRODUCTS. ACCORDING TO THE INFORMATION CURRENTLY AVAILABLE, THE CAUSE OF THIS DEATH EVENT COULD NOT BE CONFIRMED, AND THE CORRELATION WITH THE SUTURE PRODUCTS WAS VERY SMALL ACCORDING TO OUR LOCAL MEDICAL AFFAIRS TEAM. IT WAS NOT EXCLUDED THAT THE PULL OFF SUTURE NEEDLE ISSUE HAD SOME INFLUENCE ON THE SURGICAL PROCESS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342601 SUT.PROLENE AZ 6-0 75 CM C-1(2 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. TGBKKP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| D