BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7664491 · Received July 5, 2018

    Report

    Report Number
    2210968-2018-74099
    Event Type
    Death
    Date Received
    July 5, 2018
    Report Date
    June 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON ADDITIONAL INFORMATION REVIEW, THIS MEDWATCH REPORT 2210968-2018-74099 DOES NOT MEET REPORTABILITY CRITERIA AND HAS BEEN UPDATED FROM DEATH TO NOT-REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS AND PATIENT DEATHS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCT PROLENE USED IN THIS PROCEDURE? CITATION: YAO ET AL. BMC GASTROENTEROLOGY (2016) 16:69; DOI 10.1186/S12876-016-0482-8. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CONTINUOUS SUTURING WITH TWO ANTERIOR LAYERS REDUCES POST-OPERATIVE COMPLICATIONS AND HOSPITALIZATION TIME IN PANCREATICOENTEROSTOMY" AUTHOR(S): GUOLIANG YAO, YONGGANG FAN AND JINGMING ZHAI CITATION: YAO ET AL. BMC GASTROENTEROLOGY (2016) 16:69; DOI 10.1186/S12876-016-0482-8. THIS RETROSPECTIVE COMPARATIVE STUDY AIMED TO EVALUATE THE SAFETY AND EFFICACY OF THE NEW METHOD OF PANCREATICOENTEROSTOMY THAT INCLUDED THE CONTINUOUS SUTURING OF THE JEJUNUM AND THE STUMP OF THE PANCREAS END-TO-SIDE WITH ONE LAYER POSTERIORLY AND TWO LAYERS ANTERIORLY. BETWEEN SEP2011 AND MAR2014, 45 PATIENTS WITH PERI-AMPULLARY TUMORS UNDERWENT PANCREATICODUODENECTOMY WITH EITHER THE REGULAR INTERRUPTED SUTURING METHOD (N=29; N=18 MALE AND N=11 FEMALE; AGE OF 67.3 ± 7.4 YEARS) OR THE NEW CONTINUOUS MATTRESS SUTURING METHOD (N=16; N=11 MALE AND N=5 FEMALE; AGE OF 61.2 ± 6.2 YEARS). IN BOTH GROUPS, THE STUMP OF THE PANCREAS WAS INVAGINATED INTO THE JEJUNUM BY AT LEAST 2¿3 CM AND FIXED WITH 3-0 PROLENE SUTURES. THE DIFFERENCE BETWEEN THE CONTINUOUS SUTURING AND INTERRUPTED SUTURING WAS LIMITED TO THE PROCEDURE OF SUTURING THE PANCREATICOENTEROSTOMY. POSTOPERATIVELY IN INTERRUPTED SUTURING GROUP, 2 PATIENTS DIED DUE TO SEVERE HEMORRHAGING SECONDARY TO PANCREATIC LEAKAGE WITH ACTIVE BLEEDING AT STOMAS OF THE PANCREATICOJEJUNOSTOMIES; ONE DEATH DUE TO HEMORRHAGING WITHOUT PANCREATIC LEAKAGE. TWO CASES OF BLEEDING THAT PRESENTED WITH POST-OPERATIVE BLOOD DRAINAGE WERE CURED CONSERVATIVELY AND WERE SECONDARY TO PANCREATIC LEAKAGE. THE REMAINING TWO CASES OF BLEEDING WERE ALSO CURED CONSERVATIVELY, AND THESE CASES PRESENTED WITH HEMATEMESIS AND MELENA WITHOUT PANCREATIC LEAKAGE. THE REMAINING CASES OF PANCREATIC LEAKAGE WERE CURED CONSERVATIVELY, AND SECONDARY INJURIES WERE NOT FOUND. IN CONTINUOUS SUTURING GROUP, ONE PATIENT DIED DUE TO LARGE HEMORRHAGE SECONDARY TO PANCREATIC LEAKAGE. ONE PATIENT DEVELOPED PANCREATIC LEAKAGE AND ANOTHER PATIENT HAD MELENA; BOTH CURED CONSERVATIVELY. CONTINUOUS MATTRESS SUTURING IS A SAFE AND EFFECTIVE PANCREATICOENTEROSTOMY METHOD THAT LEADS TO REDUCED COMPLICATIONS AND HOSPITALIZATION TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505213 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death