BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20561834 · Received October 29, 2024

    Report

    Report Number
    2210968-2024-11213
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    July 26, 2022
    Report Date
    October 29, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: J CARD SURG. 2022; 37:5472¿5474. HTTPS://DOI.ORG/10.1111/JOCS.16912.

    Description of Event or Problem · 0

    TITLE : AORTIC ARCH REPLACEMENT AND AUTOLOGOUS PERICARDIAL TRACHEAL PATCH FOR AN AORTO-TRACHEAL FISTULA THE PRESENTED CASE WAS A 48-YEAR-OLD MAN WITH AN AORTO-TRACHEAL FISTULA INDUCED BY RADIATION THERAPY FOR TRACHEAL SQUAMOUS CELL CARCINOMA. HE PRESENTED WITH HEMOPTYSIS AND CHEST PAIN AND WORKUP REVEALED THE AORTA-TRACHEAL FISTULA BETWEEN THE POSTERIOR AORTIC ARCH AND ANTERIOR DISTAL TRACHEA. HE WAS EMERGENTLY TAKEN TO SURGERY. IN SURGICAL PROCEDURE, A 3 MM AIRWAY DEFECT WAS DEFINED FOLLOWING LIMITED DEBRIDEMENT OF SCAR AND DEVITALIZED TISSUE IN THE TRACHEA. HORIZONTAL MATTRESS SUTURES WERE PLACED CIRCUMFERENTIALLY AROUND THE DEFECT USING 4-0 PDS. ONCE THE PATIENT HAD REWARMED TO 36°C, HE WAS SUCCESSFULLY WEANED FROM CARDIOPULMONARY BYPASS AND HEMOSTASIS ACHIEVED. THE GREATER OMENTUM WAS LIBERATED FROM THE TRANSVERSE COLON, ROTATED ON THE GASTROEPIPLOIC PEDICLE, AND SECURED TO THE REPAIR WITH VISTASEAL FIBRIN SEALANT (ETHICON) TO PROVIDE VASCULARIZED TISSUE BETWEEN THE TRACHEAL REPAIR AND THE AORTIC GRAFT. THE REPORTED COMPLICATIONS REPORTED PNEUMONITIS ON POSTOPERATIVE DAY 6. IN CONCLUSION, HE WAS ULTIMATELY DISCHARGED TO A REHABILITATION FACILITY ON POSTOPERATIVE DAY 38. HE MADE A SATISFACTORY RECOVERY THEREAFTER AND WAS ALIVE AND NEUROLOGICALLY INTACT AS OF 13 MONTHS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914727 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention