BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7626932 · Received June 21, 2018

    Report

    Report Number
    2210968-2018-73640
    Event Type
    Injury
    Date Received
    June 21, 2018
    Report Date
    May 29, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    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. CITATION: SURG ENDOSC (2009) 23:2499¿2504; DOI 10.1007/S00464-009-0425-3; PUBLISHED ONLINE: 3 APRIL 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LONG-TERM RESULTS OF HIATAL HERNIA MESH REPAIR AND ANTIREFLUX LAPAROSCOPIC SURGERY" AUTHORS: E. SORICELLI, N. BASSO, A. GENCO, AND M. CIPRIANO CITATION: SURG ENDOSC (2009) 23:2499¿2504; DOI 10.1007/S00464-009-0425-3; PUBLISHED ONLINE: 3 APRIL 2009 THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE LONG-TERM RESULTS OF LAPAROSCOPIC ANTI-REFLUX SURGERY (LARS) IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD) WITH OR WITHOUT HIATAL HERNIA. FROM NOVEMBER 1992 TO MAY 2007, 297 (127 MEN AND 170 WOMEN) PATIENTS UNDERWENT LAPAROSCOPIC ANTI-REFLUX SURGERY. THESE PATIENTS WERE DIVIDED INTO 3 GROUPS, GROUP A (MEN/WOMEN- 47/46; AGE- 47.6), GROUP B (MEN/WOMEN- 49/65; AGE- 46.7), GROUP C (MEN/WOMEN- 31/59; AGE- 48.4). IN GROUP A, CRURAL CLOSURES WERE PERFORMED WITH TWO OR THREE INTERRUPTED NON-ABSORBABLE SUTURES (PROLENE) BETWEEN THE RIGHT AND LEFT DIAPHRAGMATIC PILLARS. IN GROUP B, USING AN ENDOSCOPIC MULTIFEED STAPLER (ENDOPATH; ETHICON ENDO-SURGERY, INC., (B)(4)), A 3 9 4-CM POLYPROPYLENE MESH WAS FIXED BY METAL ENDOSCOPIC STAPLES ON THE PILLARS WITHOUT SUTURING OF THE PILLARS THEMSELVES. IN GROUP C, TWO OR THREE INTERRUPTED NON-ABSORBABLE SUTURE (PROLENE) APPROXIMATED THE TWO PILLARS, AND THEN A 3 9 4-CM POLYPROPYLENE MESH WAS SUPERIMPOSED ON THE PILLARS AND FIXED USING THE ENDOPATH, WITH SPECIAL CARE TAKEN TO AVOID WRINKLES AND FREE FLAPS. IN GROUP A, 7 PATIENTS WITH A PREOPERATIVE DIAGNOSIS OF HIATAL HERNIA EXPERIENCED POSTOPERATIVE HERNIA RECURRENCE, AND 2 OF THE PATIENTS HAD WRAP MIGRATION INTO THE CHEST WITHIN 5 MONTHS. RECURRENCE WAS SYMPTOMATIC FOR SIX OF THE NINE PATIENTS WITH RECURRENCE OR WRAP MIGRATION (REGURGITATION, HEARTBURN, DYSPHAGIA), AND THEY UNDERWENT REOPERATION. THE OPERATION WAS PERFORMED LAPAROSCOPICALLY FOR ALL THE PATIENTS, WITH ONE CONVERSION. THE REMAINING THREE PATIENTS WERE ASYMPTOMATIC AND NEEDED NO FURTHER TREATMENT. DURING A MEAN FOLLOW-UP PERIOD OF 89.0 ± 29.8 MONTHS, A MESH-RELATED COMPLICATION OCCURRED FOR ONLY 1 (0.49%) OF THE 204 PATIENTS FOR WHOM POLYPROPYLENE MESH WAS USED. IN GROUP B, 2 PATIENTS WITH PREOPERATIVE HIATAL HERNIA HAD A SYMPTOMATIC RECURRENCE AND UNDERWENT LAPAROSCOPIC REOPERATION. NO PATIENT PRESENTED WITH WRAP MIGRATION. IN GROUP C, 1 PATIENTS WITH A HIATAL HERNIA EXPERIENCED A SYMPTOMATIC RECURRENCE AND UNDERWENT A LAPAROSCOPIC REOPERATION. IN THIS PATIENT, THE HIATAL ORIFICE WAS ESTIMATED TO BE 10 CM. NO PATIENT PRESENTED WITH MIGRATION. IN CONCLUSION, LAPAROSCOPIC ANTI-REFLUX SURGERY WITH A PROSTHETIC POLYPROPYLENE MESH USED TO CLOSE THE CRURA IN CASES OF HIATAL HERNIA IS AN EFFECTIVE AND SAFE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467773 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention