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

Catalog Number 1BSGTRI60B

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Adhesion(s) (1695); Inflammation (1932)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight and id were requested, but not provided.It was reported that 3 seamguard devices were used during the procedure.Device lot numbers were requested, but no information has been received.Previous patient medical history was requested, but no information has been received.Surgical op notes have been requested but have not been provided.

Event Description

A surgeon reported to gore that a patient underwent a gastric sleeve procedure using gore® seamguard® bioabsorbable staple line reinforcement (1bsgtri60b).It was reported the patient returned 8-10 days later with a high temperature and elevated crp.It was reported the patient had an endoscope but there was no evidence of a leak and the staple line was reportedly in tact.The surgeon stated the seamguard was inflamed and there were many adhesions on the staple line.The patient has been reportedly discharged.Additional ct scan with gradual resolution of odema, all clear fluid and no pus.

• Brand Name: ENDOSCOPIC GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT
• 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: cheryl hawke ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9126950
• MDR Text Key: 160738538
• Report Number: 3003910212-2019-00370
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K043056
• 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: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• 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
• 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; Required Intervention
• Patient Age: 28 YR