BEUDAMED
    FDA Adverse Event Death Summary report: N

    STLESS STEEL SIL 4X18IN 5 S/A V-40

    MDR report key: 19338163 · Received May 16, 2024

    Report

    Report Number
    2210968-2024-05415
    Event Type
    Death
    Date Received
    May 16, 2024
    Date of Event
    May 5, 2024
    Report Date
    August 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. 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. 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. DID THE SUTURE CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT? WHAT WAS THE CAUSE OF DEATH OF THE PATIENT? DID THE SUTURE CAUSE OR CONTRIBUTE TO THE LACERATION TO THE RIGHT VENTRICLE? PLEASE EXPLAIN. WHAT IS THE MEANING OF ¿3 MORE NEW PCRS¿? PROVIDE DETAILS. PLEASE PROVIDE THE PATIENT'S WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? WHAT TISSUE DEHISCED? PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. DID THE SUTURES UNTIE, BREAK, OR PULL OUT OF THE TISSUE? WERE THERE ANY PATIENT STRESS FACTORS THAT LED TO THE SUTURE UNTYING, BREAKING OR PULLING OUT OF THE TISSUE? HOW WAS THE DEHISCENCE MANAGED? PLEASE DESCRIBE ANY SURGICAL INTERVENTION REQUIRED FOR THE WOUND DEHISCENCE INCLUDING DATE AND FINDINGS. 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? PLEASE CONFIRM THE PRODUCT CODE IS BRFMZ582087. PLEASE CONFIRM THE LOT NUMBER IS AU7393?

    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. CORRECTED INFORMATION: D1, D2A, D2B, D4 CATALOG, D4 UDI NUMBER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOCARDIAL REVASCULARIZATION ON (B)(6) 2024 AND STEEL SUTURE WAS USED. THE PATIENT WAS FOLLOWED UP POST-OPERATIVELY IN THE ICU. ON (B)(6) 2024, A CONSCIOUS PATIENT WENT INTO A SEVERE COUGHING ATTACK ON DAY 5 POST OP, PATIENT ON NIV, WITH A PIP OF 9, AND REPORTED TO THE ICU NURSE FEELING AN OPENING IN THE CHEST. IT PROGRESSES TO DEHISCENCE OF THE SUTURES, REPORTED BY ANESTHESIOLOGISTS WITH POSSIBLE VISUALIZATION OF THE CAVITY UPON ARRIVAL AT THE SURGICAL CENTER, AT 1:50 PM. PATIENT UNDER ANESTHESIA SUFFERED A CARDIAC ARREST, BUT WAS RESUSCITATED AND UPON RE-APPROACH IT WAS POSSIBLE TO VERIFY THAT HE SUFFERED SOME FRACTURES IN THE STERNUM BONE, WITH EXPOSURE OF THE STEEL WIRE, WITH LACERATION OF THE RIGHT VENTRICLE. THE LACERATION WAS CORRECTED, BUT THE PATIENT WITH HIGH DOSES OF VASOACTIVE DRUGS AND BIVENTRICULAR DYSFUNCTION, PRESENTED 3 MORE NEW PCRS, BEING DECLARED DEAD AT 3:20 PM ON THE SAME DATE. PATIENT READDRESSED BY THE SURGEON. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970731 STLESS STEEL SIL 4X18IN 5 S/A V-40 SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. AU7393

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death| R