MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® PREPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Catalog Number	GKWR2025
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the instructions for use (ifu) for 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, lung function, impairment, pain, paresthesia, perforation, revision/re-surgery, seroma or hematoma and related harms, wound complications and wound dehiscence.It should be noted that the gore® synecor preperitoneal biomaterial instructions for use further states, use of absorbable sutures to secure the mesh in place may result in inadequate fixation.Ensure staple size and staple or tack spacing provides adequate fixation of device to tissue.Insufficient fixation of the device may result in mesh migration, erosion or extrusion, hernia recurrence, or recurrence of soft tissue deficiency which may lead to bowel obstruction, dysphagia, fistula, gerd recurrence, pain, and additional intervention including surgery.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.
Event or Problem Description
It was reported to gore that approximately three months ago a 20 cm x 30 cm gore® synecor preperitoneal biomaterial device was cut in half making two 15 cm x 20 cm devices to repair each side of the bilateral hernia.Absorbable vicryl sutures were used to fixate both pieces.Reportedly, the patient returned to the office 1-2 weeks ago complaining of a lump in his groin on one side.On (b)(6) 2023 the implanting physician re-operated on the patient and reportedly found heavy scar tissue and the mesh surrounded by fluid and not incorporated into tissue.The mesh was explanted and disposed of.The hernia recurrence was repaired with a piece of bard 3d max.
Additional Manufacturer Narrative
H6: corrected investigation findings code, conclusion code remains the same.According to the instructions for use (ifu) for 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, lung function, impairment, pain, paresthesia, perforation, revision/re-surgery, seroma or hematoma and related harms, wound complications and wound dehiscence.It should also be noted that the gore® synecor preperitoneal biomaterial instructions for use further warns, use of absorbable sutures to secure the mesh in place may result in inadequate fixation.Ensure staple size and staple or tack spacing provides adequate fixation of device to tissue.Insufficient fixation of the device may result in mesh migration, erosion or extrusion, hernia recurrence, or recurrence of soft tissue deficiency which may lead to bowel obstruction, dysphagia, fistula, gerd recurrence, pain, and additional intervention including surgery.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.
Additional Manufacturer Narrative
H10/11: added additional information.H6: updated type of investigation code and investigation findings code.Updated conclusion code.Additional information: it was further reported by the physician, that the patient had normal anatomy, large left indirect hernia, not incarcerated, right indirect inguinal, smaller than left.The device was not used in a load bearing manner.There was no evidence of ischemic tissue, no disruption of the inferior epigastric vessels intraoperatively.The physician stated the mesh was not sent for pathology the only lab abnormalities found are (platelets stable around 150), mild renal disease creatinine 1.20 (stable).Reportedly, there was no evidence of ischemic tissue, no disruption of the inferior epigastric vessels intraoperatively.The patient was reportedly compliant with postoperative care.Note: it was reported that absorbable vicryl sutures were used during the initial hernia repair, which is warned against in the instructions for use for the gore® synecor preperitoneal biomaterial.According to the instructions for use (ifu) for 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, lung function, impairment, pain, paresthesia, perforation, revision/re-surgery, seroma or hematoma and related harms, wound complications and wound dehiscence.It should also be noted that the gore® synecor preperitoneal biomaterial instructions for use further states, use of absorbable sutures to secure the mesh in place may result in inadequate fixation.Ensure staple size and staple or tack spacing provides adequate fixation of device to tissue.Insufficient fixation of the device may result in mesh migration, erosion or extrusion, hernia recurrence, or recurrence of soft tissue deficiency which may lead to bowel obstruction, dysphagia, fistula, gerd recurrence, pain, and additional intervention including surgery.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.D4: added serial #, catalog #, expiration date, udi # h4: added device manufacture date.

• Brand Name: GORE® SYNECOR® PREPERITONEAL BIOMATERIAL
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17778024
• Report Number: 3003910212-2023-01499
• Device Sequence Number: 5648935
• Product Code: FTL
• UDI-Device Identifier: 00733132638727
• UDI-Public: 00733132638727
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K163576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2025
• Device Catalogue Number: GKWR2025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/29/2023; 08/29/2023; Not provided
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/30/2023; 12/08/2023; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male