MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT; MESH, SURGICAL

Catalog Number	12BSGEC60
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Form Staple (2579)
Health Effect - Clinical Codes	Organ Dehiscence (2502); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Gore received notification of a complaint and complainant details were received by psg on (b)(6), 2024.Communication with the complainant's counsel is being handled outside of product surveillance.A2 and a4: age and weight were not provided.The gore® seamguard® bioabsorbable staple line reinforcement instructions for use (ifu) states: possible adverse reactions may include, but are not limited to: adhesions, hematoma, infection, and inflammation.Refer to ifu section warning and precautions for any additional information regarding adverse events and any steps that should be taken to avoid them, as well as information about other warnings and precautions.Adverse events potential device or procedure-related adverse events possible adverse reactions and complications that may occur with the use of gore® seamguard® bioabsorbable staple line reinforcement or in any endoscopic surgical procedure and may require intervention include, but are not limited to (shown in english alphabetical order): ¿ adhesions ¿ blood loss ¿ hematoma ¿ infection ¿ inflammation ¿ leaks 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
At numerous times throughout 2023, the patient called and emailed gore inquiring as to whether gore shipped the ethicon stapler with its seamguard device.The patient reported she has stomach cancer and staples were coming undone as a result of her physician using a recalled ethicon stapler.Various gore employees advised the patient numerous times throughout 2023 that gore did not sell or ship the ethicon stapler.On (b)(6), 2024 the patient filed a lawsuit against gore alleging the echelon flex endopath stapler reload (black, 60 mm x 4.4 mm, model no.Ecr60t) and the gore® seamguard® bioabsorbable staple line reinforcement, product 12bsgec60 were defective products used in the gastric sleeve surgery performed on (b)(6), 2016.Reportedly, the patient alleges these products caused the incomplete staple line formation resulting in gastric leak complications.The patient reported she has undergone continuous treatment for her injuries caused by the defective products and resulting gastric leak, including, but not limited to, removal of her spleen, removed of her left lower lung lobe, an esophagoscopy, gastroscopy, duodenoscopy for a pleural fistula, repair of s diaphragmatic hernia, internal wound vac procedures and extensive pain and suffering.
Additional Manufacturer Narrative
D17: appropriate code/term not available for ¿withdrawn complaint¿.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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 an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".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.

• Brand Name: GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT
• Common Device Name: MESH, SURGICAL
• 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: angela brown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18620629
• Report Number: 3003910212-2024-01540
• Device Sequence Number: 2369046
• Product Code: FTM
• UDI-Device Identifier: 00733132600335
• UDI-Public: 00733132600335
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 06/30/2018
• Device Catalogue Number: 12BSGEC60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2015
• 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: Other; Hospitalization
• Patient Sex: Female