BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8345699 · Received February 15, 2019

    Report

    Report Number
    2210968-2019-78926
    Event Type
    Injury
    Date Received
    February 15, 2019
    Report Date
    February 1, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CITATION: SURG ENDOSC. 2003; 17: 1372¿1375. DOI: 10.1007/S00464-002-9192-0.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC MANAGEMENT OF LARGE PARAESOPHAGEAL HIATAL HERNIA." AUTHORS: P.C. LEEDER, G. SMITH, T.C.B. DEHN. CITATION: SURG ENDOSC. 2003; 17: 1372¿1375. DOI: 10.1007/S00464-002-9192-0. LARGE PARAESOPHAGEAL HERNIAS (POHS) PREDOMINANTLY OCCUR IN THE ELDERLY POPULATION. EARLY REPAIR IS RECOMMENDED TO AVOID THE RISKS ASSOCIATED WITH GASTRIC VOLVULUS. DATA WERE COLLECTED PROSPECTIVELY DURING AN 8-YEAR PERIOD. LAPAROSCOPIC REPAIR OF POHS INITIALLY INCLUDED CIRCUMCISION OF THE SAC AND MESH HIATAL REPAIR. A TOTAL OF 53 PATIENTS WITH LARGE POHS WERE TREATED AND INCLUDED IN THE STUDY. OF WHICH, 14 PATIENTS WERE RANDOMIZED IN THE MESH REPAIR GROUP (GROUP M; 3 MALE AND 11 FEMALE PATIENTS; AGE RANGE: 61 TO 85 YEARS), SUTURED REPAIR GROUP (GROUP S; 11 MALE AND 26 FEMALE PATIENTS; AGE RANGE: 45 TO 92 YEARS OLD), AND THE GASTROPEXY ALONE GROUP (GROUP G; 1 MALE AND 1 FEMALE PATIENT; AGE RANGE: 71 TO 74 YEARS OLD). INITIALLY, STAPLED MESH WAS USED IN GROUP M. POLYPROPYLENE HERNIA MESH (ETHICON) WAS CUT INTO THE SHAPE OF THE ¿¿ARC DE TRIOMPHE.¿¿ THE MESH WAS INTRODUCED INTO THE ABDOMINAL CAVITY AND POSITIONED OVER THE HIATUS ANTERIORLY TO ALLOW FREE PASSAGE OF THE ESOPHAGUS THROUGH THE ARC. IN GROUP S, THE CRURAL DEFECT WAS REPAIRED BY DIRECT INTERRUPTED SUTURE USING ETHIBOND 0 SUTURES (ETHICON). IF POSTERIOR CLOSURE COULD NOT BE COMPLETED, ANTERIOR SUTURES WERE PLACED TO AVOID EXCESSIVE TENSION OF THE CRURAL REPAIR. WHEN A CONCOMITANT FUNDOPLICATION WAS UNDERTAKEN IN GROUP S, THE MOBILITY OF THE FUNDUS WAS ASSESSED AND, IF NECESSARY, SHORT GASTRIC VESSELS WERE DIVIDED EITHER BY USE OF A HARMONIC SCALPEL (ETHICON) OR, IN EARLY CASES IN THE SERIES, BY DIVISION BETWEEN HEMOSTATIC CLIPS. ALL PATIENTS, INCLUDING GROUP G UNDERWENT GASTROPEXY AT TWO PORT SITES. FIXATION WAS PERFORMED BY WITHDRAWING A PORTION OF THE ANTERIOR WALL OF THE STOMACH THROUGH THE EPIGASTRIC AND LEFT UPPER QUADRANT PORT INCISIONS USING ENDO-BABCOCK FORCEPS. PNEUMOPERITONEUM WAS EVACUATED AND THE STOMACH WAS THEN SUTURED TO THE ABDOMINAL WALL MUSCLE BY TYING EXTERNALLY USING ETHIBOND 1-0 SUTURE (ETHICON). IN GROUP M, REPORTED COMPLICATIONS INCLUDED NEW SYMPTOMS OF GASTROESOPHAGEAL REFLUX (N-5) AND SYMPTOMATIC HERNIA RECURRENCE (N-2) WHICH REQUIRED OPEN REPAIR WITH GOOD RESULTS IN 1 PATIENT AND THE SECOND PATIENT REFUSED FURTHER SURGERY. IN GROUP S, REPORTED COMPLICATIONS INCLUDED INTRAOPERATIVE ESOPHAGEAL PERFORATION (N-2) WHICH REQUIRED SUTURE REPAIR IN 1 PATIENT AND REPAIRED SUCCESSFULLY LAPAROSCOPICALLY IN 1 PATIENT, BRISK HEMORRHAGE FROM AN OMENTAL VESSEL (N-1) WHICH REQUIRED SUTURE REPAIR, NEW SYMPTOMS OF GASTROESOPHAGEAL REFLUX (N-4), AND SMALL SLIDING HERNIA (N-1) WHICH WAS SUCCESSFULLY REPAIRED BY OPEN SURGERY. IN GROUP G, REPORTED COMPLICATIONS INCLUDED NEW SYMPTOMS OF GASTROESOPHAGEAL REFLUX (N-1) AND RECURRENCE (N-2) WHICH WAS TREATED BY OPEN REVISIONAL SURGERY IN 1 PATIENT AND THE OTHER PATIENT DECLINED FURTHER SURGERY. AS A RESULT OF THE PRESENTED EXPERIENCE WITH LAPAROSCOPIC REPAIR OF POHS, THE AUTHORS ADVOCATED THE FOLLOWING PROCEDURE, EXCISION OF THE HERNIAL SAC, CLOSURE OF THE HIATAL DEFECT, A FUNDOPLICATION, AND A GASTROPEXY. IRRESPECTIVE OF AGE, MASSIVE CRURAL DEFECTS IN PATIENTS WITH SEVERELY ATTENUATED CRURA MAY BE SAFELY CLOSED BY STAPLED MESH REPAIR. WHEN THE CRURAL DEFECT IS MODERATE (THE MAJORITY) AND CRURAL MUSCLE FIBERS REMAIN, A SUTURED REPAIR MAY BE EMPLOYED. SIMPLE REDUCTION AND GASTROPEXY CAN NO LONGER BE ADVOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136922 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention