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

Catalog Number 1BSGTRI60B

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Nausea (1970)

Event Date 06/29/2019

Event Type  Injury  

Manufacturer Narrative

Explant date was confirmed as (b)(6) 2019.According to the reported information, the patient presented 5 weeks later, therefore the estimated date of event will be (b)(6) 2019.The explanted device is not being returned to gore for analysis.However the histological analysis from the hospital is attached.According to the gore® seamguard® bioabsorbable staple line reinforcement instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection, inflammation, adhesions and hematoma.

Event Description

It was reported that a patient underwent a gastric sleeve procedure using gore® seamguard® bioabsorbable staple line reinforcement.It was reported the seamguard was adherent to the diaphragm, pancreas and omentum, which required extensive dissection to free and unkink the sleeve.Theatre laparoscopy with dense adhesions and inflammation along the staple line were noted.It was reported it felt rock hard along the entire length of where the seamguard was implanted.Endoscopy showed some mid body angulation and it was reported the patient was unable to tolerate a barium swallow.It was reported to gore that after 5 weeks the patient came in reporting complete intolerance for liquids and solids.The patient reported nausea immediately post operatively.It was reported the patient has gone home and is doing well, however will need additional scopes and treatment.

• Brand Name: GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: angela brown ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8958902
• MDR Text Key: 156578710
• Report Number: 3003910212-2019-00313
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K030782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 1BSGTRI60B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 37 YR