BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 15670469 · Received October 25, 2022

    Report

    Report Number
    2210968-2022-08762
    Event Type
    Death
    Date Received
    October 25, 2022
    Date of Event
    June 10, 2021
    Report Date
    October 25, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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/DEATH 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? WOULD THE JOURNAL AUTHOR / PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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 2210968-2022-08759, 2210968-2022-08760, 2210968-2022-08761. CITATION: J. CLIN. MED. 2021; 10 (2573):1-10. HTTPS://DOI.ORG/10.3390/JCM10122573.

    Description of Event or Problem · 0

    TITLE: DEVELOPMENT OF A NOVEL DORSAL INCISION ONLY INVAGINATION TYPE PANCREATOGASTROSTOMY (CHARITÉ-PG) FOLLOWING OPEN PANCREATICODUODENECTOMY¿A SINGLE CENTRE EXPERIENCE. THIS RETROSPECTIVE SINGLE-CENTRE STUDY AIMED TO PROVIDE A NEW TECHNIQUE FOR INVAGINATION TYPE PG WITHOUT VENTRAL GASTROTOMY, THE CHARITÉ-ANASTOMOSIS (FURTHER REFERRED TO AS DORSAL INCISION ONLY PG; DIOPG) AND COMPARE IT TO A CLASSIC INVAGINATION TYPE PG (VENTRAL GASTROTOMY PG; VGPG) FOR OUTCOME PARAMETERS SUCH AS THE INCIDENCE OF COMMON COMPLICATIONS (E.G., POPF, PPH, DGE) AS WELL AS MORTALITY-RATES AND FOLLOW-UP. BETWEEN JANUARY 2017 AND DECEMBER 2019, A TOTAL OF 141 PATIENTS [68 MALES AND 73 FEMALE; MEAN AGE OF 64 YEARS (23¿88 YEARS)] WERE INCLUDED IN THE STUDY. AMONG THEM, 49 PATIENTS, WHO UNDERWENT RECONSTRUCTION VIA DIOPG, AND 92 CONSECUTIVE PATIENTS, WHO UNDERWENT RESTORATION VIA VGPG. OUT OF ALL PATIENTS, 78.3% UNDERWENT RESECTION FOR MALIGNANT TUMOUR (N = 73.8), INCLUDING PANCREATIC ADENOCARCINOMA, DISTAL BILE DUCT CARCINOMA, DUODENAL CARCINOMA AND SARCOMA. BOTH SURGERY WAS PERFORMED USING PROLENE® 4/0 (ETHICON) AND PDS® (4/0 WITH MH1 NEEDLE, 5/0; ETHICON). REPORTED COMPLICATIONS INCLUDE DEATH DUE TO SEVERE BLEEDING (N=1), POSTOPERATIVE PANCREATIC FISTULA BIOCHEMICAL LEAK (N=5), POSTOPERATIVE PANCREATIC FISTULA B (N=18), POSTOPERATIVE PANCREATIC FISTULA C (N=5), POSTOPERATIVE PANCREATIC HAEMORRHAGE A (N=5), POSTOPERATIVE PANCREATIC HAEMORRHAGE B (N=12), POSTOPERATIVE PANCREATIC HAEMORRHAGE C (N=2), DELAYED GASTRIC EMPTYING (N=28), PANCREATOGASTROSTOMY INSUFFICIENCY (N=7), INSUFFICIENCY OF THE HEPATICOJEJUNOSTOMY (N=11), FASCIA DEHISCENCE (N=1), SEVERE INTRAABDOMINAL BLEEDING (N=1), POSTOPERATIVE ILEUS (N=1), AND ABDOMINAL COMPARTMENT (N=1). IN CONCLUSION, THE AUTHORS PROVIDE A FEASIBLE AND SAFE TECHNIQUE FOR RESTORATION FOLLOWING PD VIA OUR NOVEL DIOPG, CAUSING FEWER CASES OF DGE. NEVERTHELESS, PANCREATICO-ENTERIC ANASTOMOSES REQUIRE EXPERTISE AND EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2760318 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D