BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® SYNECOR® PREPERITONEAL BIOMATERIAL

    MDR report key: 14893598 · Received July 1, 2022

    Report

    Report Number
    3003910212-2022-01385
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    March 18, 2021
    Report Date
    July 1, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K163576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿EARLY CLINICAL AND PATIENT-REPORTED OUTCOMES OF A NEW HYBRID MESH FOR INCISIONAL HERNIA REPAIR¿. JOURNAL OF SURGICAL RESEARCH, 2021 (265) 49-59 HTTPS://DOI.ORG/10.1016/J.JSS.2021.03.030. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® SYNECOR PREPERITONEAL BIOMATERIAL, AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS, WITH OR WITHOUT MESH, THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, HERNIA RECURRENCE, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RESURGERY, SEROMA OR HEMATOMA AND RELATED HARMS, WOUND COMPLICATIONS AND WOUND DEHISCENCE. NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W.L. GORE INTERNAL CASE NUMBER. WEIGHT WAS REQUESTED, BUT NOT PROVIDED. DATE OF EVENT WAS REQUESTED, BUT NOT PROVIDED, THEREFORE THE DATE THE ARTICLE WAS ACCEPTED WILL BE USED. REVIEW OF THE MANUFACTURING RECORDS AND ENGINEERING EVALUATION COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED TO GORE. (B)(4).. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿EARLY CLINICAL AND PATIENT-REPORTED OUTCOMES OF A NEW HYBRID MESH FOR INCISIONAL HERNIA REPAIR¿ JOURNAL OF SURGICAL RESEARCH, 2021 (265) 49-59 HTTPS://DOI.ORG/10.1016/J.JSS.2021.03.030. THE ARTICLE WAS ACCEPTED MARCH 18, 2021. ADULT ( > 18 Y OLD) PATIENTS UNDERGOING VENTRAL HERNIA REPAIR (VHR) WITH GORE® SYNECOR PREPERITONEAL BIOMATERIAL TM MESH BY A SINGLE SURGEON BETWEEN JANUARY 2017- MAY 2019 WITH =1-Y FOLLOW-UP WERE IDENTIFIED. THE MEDIAN AGE WAS 54.1 Y (IQR 43.1-59.7) AND THE MAJORITY WERE MALE (68.6%), NON-HISPANIC WHITE (68.6%) WITH A MEDIAN BMI OF 33.2 KG/M 2 . THE RATE OF SURGICAL SITE OCCURRENCES WAS 37.1%, WITH ONLY ONE PATIENT (2.9%) REQUIRING PARTIAL MESH REMOVAL/SURGICAL INTERVENTION. NO PATIENTS DEVELOPED A HERNIA RECURRENCE. THE MESH WAS PLACED IN A SUBLAY (RETRORECTUS) FASHION IN MOST CASES (97.1%). THE ONLY REOPERATION CORRESPONDED TO A POSTOPERATIVE SEROMA AND NON- HEALING WOUND THAT REQUIRED EXCISIONAL DEBRIDEMENT AND PARTIAL MESH REMOVAL. MULTIPLE ATTEMPTS WERE MADE TO GET ADDITIONAL INFORMATION, HOWEVER NO RESPONSE FROM THE COMPLAINANT/AUTHOR WAS RECEIVED, THE CASE WILL BE CLOSED WITH THE REPORTED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548784 GORE® SYNECOR® PREPERITONEAL BIOMATERIAL MESH, SURGICAL, POLYMERIC FTL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other| H