BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 15683621 · Received October 27, 2022

    Report

    Report Number
    2210968-2022-08861
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    August 9, 2021
    Report Date
    October 27, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-08859 AND 2210968-2022-08860. CITATION: INDIAN JOURNAL OF SURGICAL ONCOLOGY (DECEMBER 2021) 12(4):729¿736 HTTPS://DOI.ORG/10.1007/S13193-021-01415-4.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC REPAIR OF ACUTE POST-ESOPHAGECTOMY DIAPHRAGMATIC HERNIATION FOLLOWING MINIMAL ACCESS ESOPHAGECTOMY. THIS STUDY¿S OBJECTIVE WAS TO ASSESS THE PRESENTATION, INCIDENCE, OPERATIVE APPROACH, AND OUTCOMES OF ACUTE SYMPTOMATIC POSTESOPHAGECTOMY DIAPHRAGMATIC HERNIA (PEDH), FOLLOWING MINIMAL ACCESS ESOPHAGECTOMY (MAE) FOR ESOPHAGEAL AND GASTROESOPHAGEAL JUNCTIONAL CANCER. BETWEEN JANUARY 2010 AND DECEMBER 2020, ALL CONSECUTIVE PATIENTS UNDERGOING ESOPHAGECTOMY WERE RETROSPECTIVELY ANALYZED. ACUTE SYMPTOMATIC PEDH OCCURRED IN 4 PATIENTS OUT OF 680 CONSECUTIVE PATIENTS UNDERGOING ESOPHAGECTOMY AND 636 MAE. CASE 2: A 65-YEAR-OLD MALE PATIENT UNDERWENT LAPAROSCOPIC-ASSISTED TRANSHIATAL ESOPHAGECTOMY WITH GASTRIC PULL-UP AND CERVICAL ESOPHAGO-GASTRIC ANASTOMOSIS. A 3- TO 4-CM-WIDE GASTRIC TUBE WAS CREATED WITH INTERRUPTED PDS 2¿0 SUTURES OR STAPLERS DEPENDING ON THE SURGEON¿S DISCRETION. THE MECHANICAL STAPLED LINE WAS BUTTRESSED WITH A 2¿0 PDS SUTURE. POST-OP, PATIENT DEVELOPED HERNIA WHICH WAS REDUCED WITH PROLENE 2¿0 SUTURES. THE PATIENT DEVELOPED ANASTOMOTIC SITE RECURRENCE WITHIN 2 MONTHS. CASE 3: A 56-YEAR-OLD MALE PATIENT UNDERWENT LAPAROSCOPIC-ASSISTED TRANSHIATAL ESOPHAGECTOMY WITH CERVICAL GASTRO-ESOPHAGEAL ANASTOMOSIS FOR A T2N0 GASTRO-ESOPHAGEAL JUNCTION MUCINOUS ADENOCARCINOMA. A 3- TO 4-CM-WIDE GASTRIC TUBE WAS CREATED WITH INTERRUPTED PDS 2¿0 SUTURES OR STAPLERS DEPENDING ON THE SURGEON¿S DISCRETION. THE MECHANICAL STAPLED LINE WAS BUTTRESSED WITH A 2¿0 PDS SUTURE. HE UNDERWENT REVISION ESOPHAGO-GASTRIC ANASTOMOSIS FOR CONDUIT BLEED AND WAS DISCHARGED ON THE 22ND POST-OPERATIVE DAY. THE PATIENT DID NOT TURN TO FOLLOW-UP. IN CONCLUSION, ACUTE SYMPTOMATIC PEDH IS A RARE COMPLICATION AFTER TRANSHIATAL ESOPHAGECTOMY AND MAINLY OCCURS IN THE LEFT HEMITHORAX. THE INCIDENCE APPEARS TO BE LESS THAN 1% AFTER MAE. LAPAROSCOPIC REPAIR IS FEASIBLE IN MOST CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802182 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention