BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18857884 · Received March 7, 2024

    Report

    Report Number
    2210968-2024-02635
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    February 18, 2023
    Report Date
    March 7, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-02636. CITATION: ANNALS OF SURGICAL ONCOLOGY 2023. HTTPS://DOI.ORG/10.1245/S10434-023-13114-1.

    Description of Event or Problem · 0

    TITLE: NOVEL NON-DUCT-TO-MUCOSA PANCREATICOJEJUNOSTOMY RECONSTRUCTION AFTER PANCREATICODUODENECTOMY: FOCUS ON THE OCCURRENCE OF POST-PANCREATECTOMY HEMORRHAGE AND INTRA-ABDOMINAL ABSCESS THE AIM OF THIS STUDY IS TO COMPREHENSIVELY DESCRIBE THIS TECHNICAL PROCEDURE AND COMPARED THE RESULTS WITH THOSE AFTER THE CONVENTIONAL DUCT-TO-MUCOSA TECHNIQUE, FOCUSING IN PARTICULAR ON THE OCCURRENCE OF PPH AND IAA. ALL PATIENTS UNDERGOING PD WITH PJ ANASTOMOSIS FOR PERIAMPULLARY LESIONS FROM (B)(6) 2012 TO (B)(6) 2021 WERE INCLUDED. A TOTAL OF 1064 PD PATIENTS WERE ENROLLED IN THE STUDY. 535 (50.3%) PATIENTS IN THE HISTORICAL CONTROL GROUP AND 529 PATIENTS (49.7%) IN TIEN¿S GROUP. DURING THE PANCREATICOJEJUNAL ANASTOMOSIS PROCEDURE (TIEN¿S GROUP), ONE PURSE-STRING SUTURE AROUND THE PANCREATIC DUCT WAS PERFORMED WITH FIXATION OF THE PANCREATIC STENT BY 4-0 MONOCRYL (ETHICON). FURTHERMORE, ONE U-SHAPED SILK-TYPE SUTURE AROUND THE PANCREATIC DUCT (P-DUCT U-SHAPED TIE) WAS MADE AND THE STITCH WAS LEFT IN SITU. FOR THE OUTER ROW, ADDITIONAL INTERRUPTED U-SHAPED SILK-TYPE SUTURES WERE MADE WITH THE NEEDLE OF A 4-0 VASCUFIL TO PENETRATE THE PANCREATIC PARENCHYMA WHICH WAS REPLACED APPROXIMATELY 0.5 CM FROM THE CUT EDGE OF THE PANCREATIC REMNANT. NEXT, ONE CONTINUOUS RUNNING SUTURE BETWEEN THE SEROMUSCULAR JEJUNAL POSTERIOR LAYER AND POSTERIOR PANCREATIC CAPSULE WAS UNDERTAKEN BY 3-0 POLYPROPYLENE (PROLENE, ETHICON) TO APPROXIMATE THE JEJUNUM TO THE DORSAL PART OF THE PANCREATIC REMNANT. FINALLY, ANOTHER CONTINUOUS RUNNING SUTURE BETWEEN THE SEROMUSCULAR JEJUNAL ANTERIOR LAYER AND ANTERIOR PANCREATIC CAPSULE WAS PERFORMED WITH 3-0 POLYPROPYLENE (PROLENE, ETHICON) TO APPROXIMATE THE JEJUNUM TO THE VENTRAL FACE OF THE PANCREATIC REMNANT. AND DURING CONVENTIONAL PJ ANASTOMOSIS (HISTORICAL CONTROL GROUP), THE POSTERIOR AND ANTERIOR CAPSULES WAS SUTURED WITH CONTINUOUS RUNNING SUTURES WITH THE SEROMUSCULAR JEJUNUM WITH 3-0 POLYPROPYLENE (PROLENE, ETHICON). REPORTED COMPLICATION: HEMORRHAGE (N-40) PANCREATIC FISTULA (N-483) INTRA-ABDOMINAL ABSCESS (N-88) CONCLUSION EVIDENCE FROM OUR STUDY DEMONSTRATES THAT NON-DUCT-TO MUCOSA PJ ANASTOMOSIS WITH ONE PURSE-STRING SUTURE ON THE JEJUNAL LIMB FOR LIMITING BILE/INTESTINAL LEAKAGE WAS ASSOCIATED WITH A LOWER RATE OF PPH AND IAA FORMATION THAN THE CONVENTIONAL DUCT-TO-MUCOSA METHOD. WE CONSIDER THIS TECHNIQUE TO BE SIMPLE AND SAFE FOR PD PATIENTS, HOWEVER FURTHER PROSPECTIVE STUDIES SHOULD BE CONDUCTED TO VALIDATE ITS CLINICAL BENEFIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742193 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other