BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21378208 · Received February 13, 2025

    Report

    Report Number
    2210968-2025-01650
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    June 7, 2024
    Report Date
    February 13, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: LANGENBECK'S ARCHIVES OF SURGERY HTTPS://DOI.ORG/10.1007/S00423-024-03366-0.

    Description of Event or Problem · 0

    TITLE:ONE HUNDRED CONSECUTIVE PANCREATIC RESECTIONS USING A NOVEL PANCREATICO-JEJUNOSTOMY TECHNIQUE. THIS AIM OF THIS SINGLE-CENTRE AND SINGLE-SURGEON STUDY WAS TO EVALUATE THE FEASIBILITY AND PATIENT OUTCOMES OF A SIMPLIFIED TECHNIQUE INVOLVING A SINGLE-LAYER CONTINUOUS PANCREATICOJEJUNOSTOMY (PJA). BETWEEN MARCH 2018 TO MARCH 2022, A TOTAL OF 100 PATIENTS WERE INCLUDED (59 MALE AND 41 FEMALE, MEAN 66.2 ± 10.6 YEARS OLD). ALL PATIENT UNDERWEANT PANCREATIC RESECTIONS WITH THE PJAS BEING PERFORMED BY A SINGLE SURGEON (RHB). PRIOR TO DIVISION OF THE PANCREAS WITH ELECTROCAUTERY, 3/0 PROLENE STAY SUTURES WERE PLACED 1CM AWAY FROM THE INTENDED LINE OF TRANSECTION AT THE SUPERIOR AND INFERIOR PANCREATIC BORDERS RESPECTIVELY. THE PJA IS THEN COMMENCED WITH A CONTINUOUS DOUBLE ARMED 3/0 PROLENE SUTURE. THE PREVIOUSLY PLACED 3/0 PROLENE STAY SUTURES ARE MANOEUVRED TO THE LEFT OF THE SURGICAL FIELD SUCH THAT THE POSTERIOR ASPECT OF THE PANCREAS WAS EXPOSED. THE 3/0 PROLENE SUTURE WAS THEN PASSED THROUGH THE FULL THICKNESS OF THE SUPERIOR BORDER OF THE PANCREAS 2CM LATERAL TO THE SUPERIOR 3/0 PROLENE STAY SUTURE SUCH THAT ONE SUTURE WAS ON THE ANTERIOR ASPECT OF THE PANCREAS AND ONE SUTURE WAS ON THE POSTERIOR ASPECT OF THE PANCREAS. THE STAY SUTURES ARE THEN TIED AND CUT. THE ANTERIOR WALL OF THE PJA IS THEN COMPLETED IN THE SAME MANNER AS DESCRIBED ABOVE UNTIL THE 3/0 PROLENE SUTURES MEET EACH OTHER. THESE ARE THEN TIED (RED AND BLUE). THE PJA IS THEN COMPLETED BY WRAPPING THE FALCIFROM LIGAMENT AROUND THE ANASTOMOSIS AND FIXED INTO POSITION WITH 3/0 VICRYL. MEAN FOLLOW UP FOR 5 YEARS. REPORTED COMPLICATIONS INCLUDE PATIENTS : - POST PANCREATECTOMY HEMORRHAGE (N=1) TREATMENT: NO TREATMENT PROVIDED. - BIOCHEMICAL LEAK (N=17) TREATMENT: NONE OF WHOM REQUIRED ANY INTERVENTION. - DELAYED GASTRIC EMPTYING (N=6) TREATMENT: NOT SPECIFIED BUT WAS GRADED AS CLAVIEN DINDO > 3A COMPLICATIONS - CHYLE LEAK (N=5) TREATMENT: NOT SPECIFIED BUT WAS GRADED AS CLAVIEN DINDO > 3A COMPLICATIONS - PSEUDOANEURYSM (N=2) TREATMENT: THAT WERE MANAGED WITH RADIOLOGICAL EMBOLIZATION - POST-OPERATIVE PANCREATIC FISTULA TYPE B AND C (N=14) TREATMENT: NOT REPORTED - RIGHT COLONIC ISCHAEMIA (N=1) TREATMENT: REQUIRING RIGHT HEMICOLECTOMY AND ILEOSTOMY FORMATION - INTRALUMINAL BOWEL HAEMORRHAGE (N=1) TREATMENT: REQUIRED MULTIPLE RELOOK LAPAROTOMIES IN CONCLUSION, THE CURRENT STUDY HAS LIMITATIONS. IN PARTICULAR THERE IS NO MATCHED DUCT-TO-MUCOSA COMPARATOR GROUP AND ALL PJAS WERE PERFORMED BY A SINGLE SURGEON AT A SINGLE CENTRE AND THEREFORE, THE GENERALITY AND APPLICABILITY CAN BE QUESTIONED. THE STUDY IS ALSO RETROSPECTIVE AND MULTIVARIATE ANALYSIS WAS NOT FEASIBLE. PD IS AN OPERATION THAT DEMANDS PROFICIENCY OF TECHNICAL SKILLS TO ACHIEVE THE LOWEST MORBIDITY RATE, THE SINGLE-LAYER CONTINUOUS DUNKING PJA PRESENTED IN THIS STUDY IS A SIMPLIFIED AND FEASIBLE METHOD FOR PJA WITH EQUIVALENCE TO INTERNATIONAL OUTCOME STANDARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880774 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention