BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18681537 · Received February 9, 2024

    Report

    Report Number
    2210968-2024-01223
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 1, 2020
    Report Date
    March 19, 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
    MK
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ALL THE ETHICON PRODUCTS ARE MOST LIKELY ENTIRELY CLOSE TO THE IDEAL DESIRED AND DELIVERED QUALITY, PARTICULARLY FOR THE PURPOSE THEY ARE INVENTED AND DESIGNED FOR.

    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. RELATED EVENTS CAPTURED VIA 2210968-2024-01223, 2210968-2024-01224. CITATION: CONTRIBUTIONS. SEC. OF MED. SCI., XLI 3, 2020. HTTPS://DOI.ORG/10.2478/PRILOZI-2020-0044.

    Description of Event or Problem · 0

    TITLE: COMPARISON BETWEEN DUNKING (INVAGINATION) PANCREATICOJEJUNOANASTOMOSIS AND DOUBLE LAYER DUCT TO MUCOSA ANASTOMOSIS AFTER CEPHALIC DUODENOPANCREATECTOMY-WHIPPLE PROCEDURE FOR PANCREATIC CEPHALIC CARCINOMA THE OBJECTIVE OF THE STUDY WAS TO COMPARE THESE 2 SUTURING TECHNIQUES WE APPLIED, AND THE AIM WAS TO REVEAL THE RISK BENEFIT RATIONALE FOR DUNKING EITHER DUCT TO MUCOSA ANASTOMOSIS. DURING THE LAST 14 MONTHS, A TOTAL OF 25 PATIENTS WITH PANCREATIC CEPHALIC CARCINOMA (PCC) UNDERWENT STANDARD DUODENOPANCREATECTOMY (SDP). INVAGINATION-DUNKING ANASTOMOSIS (DA) WAS PERFORMED IN 15, WHEREAS, DUCT-TO-MUCOSA, DOUBLE LAYER ANASTOMOSIS (DMA) WAS PERFORMED IN 10. IN THE FIRST GROUP WITH DUNKING ANASTOMOSIS, WE HAD 6 PATIENTS WITH SOFT PANCREAS AND 8 WITH NARROW MAIN PANCREATIC DUCT (MPD), LESS THAN 3 MM. IN THE DUCT-TO-MUCOSA GROUP THERE WERE 5 PATIENTS WITH SOFT PANCREAS AND 4 WITH NARROW MAIN PANCREATIC DUCT. ALL OTHER STAGES OF SURGERY WERE UNIFIED, SO THE ONLY DIFFERENCE IN THE PROCEDURE REMAINED ON THE PANCREATOJEJUNOANASTOMOSIS (PJA). THE CREATION OF PJA IN THE DA GROUP WAS WITH 4-0 PROLENE INTERRUPTED SUTURES, 3-5 MM DISTANCE OF THE RESECTION MARGIN, ON THE CAPSULE OF THE PANCREAS. ON THE JEJUNUM THE SUTURE WAS SEROMUSCULAR. THIS TECHNIQUE ENABLES INVERTING THE PANCREATIC STUMP IN TO THE LUMEN OF THE JEJUNUM. THIS ANASTOMOSIS WAS FACILITATED WITH A SPLINTING CATHETER ¿ INTERNAL STENT PLACED IN THE MPD (FIGURE 1). THE PJA IN DMA GROUP, WAS CREATED IN 2 LAYERS, INTERRUPTED SUTURES, PROLENE 4-0. THE EXTERNAL LAYER WAS ON THE CAPSULE OF THE PANCREAS AND SEROMUSCULAR LAYER OF THE JEJUNUM. THE SECOND, INTERNAL LAYER WAS SAWN WITH PROLENE 5-0, 4-6 INTERRUPTED SUTURES, DEPENDING ON THE CALIBER AND TOPOGRAPHY OF THE MPD. THE SUTURES WERE PLACED ON THE WALL OF THE MPD AND THE JEJUNAL MUCOSA (FIGURE 2). REPORTED COMPLICATIONS INCLUDE BIOCHEMICAL-PANCREATIC LEAKAGE (N=3), POSTOPERATIVE PANCREATIC FISTULA B (N=4), AND WOUND INFECTIONS (N=7). IN CONCLUSION, ACCORDING TO THE RESULTS WE RETRIEVED IN OUR STUDY, DMA IS SUPERIOR OVER DA AFFECTING THE MORBIDITY MAINLY PRESENTED BY CLINICALLY RELEVANT POPF. ACCEPTING THE INVERSE RESULTS REVEALED IN OTHER STUDIES, WE BELIEVE THAT FURTHER BIG PROSPECTIVE RCTS WOULD BE NECESSARY TO CLARIFY THIS DILEMMA. THESE PREDICTED TRIALS WOULD DEAL WITH MANY AND FAIRLY STRATIFIED GROUPS AND SUBGROUPS DEPENDING ON MANY RISK FACTORS AS VARIABLES, (I.E. SOFT PANCREAS, NARROW MAIN PANCREATIC DUCT, LIVER DISEASE, CARDIOVASCULAR DISEASES, PULMONARY DISEASES, PREOPERATIVE RADIOGRAPHIC STAGE OF THE DISEASE, AGE, ETC.) AND WOULD FIRMLY CONTRIBUTE TO ACHIEVE AN ATTITUDE FOR THE TYPE OF PJA ELIGIBLE AND FAVORABLE TO ANY GROUP OR SUBGROUP OF PATIENTS SUFFERING PC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68815 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention