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

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Article publication: obesity surgery (2020) 30:3982¿3987 https://doi.Org/10.1007/s11695-020-04767-y.The date the article was published online was june 17, 2020, therefore this will be the estimated date of event.Multiple attempts were made to obtain additional information about this event.No additional information was provided therefore, the case will be closed.Due to an unknown lot/serial number and no device return, a manufacturing/engineering investigation could not be performed.(b)(4).Per the instructions for use (ifu) for gore® seamguard® bioabsorbable staple line reinforcement, possible adverse reactions may include, but are not limited to: infection, inflammation, adhesions and hematoma.

Event Description

According to a study, ¿weight regain after gastric plication: reoperative sleeve gastrectomy or roux-en-y gastric bypass?¿analysis of 116 consecutive cases¿ published by elias chahine published online june 17, 2020.The use of the gore® seamguard® bioabsorbable staple line reinforcement was evaluated in patients undergoing revisional surgery post-gastric plication.Between february 2010 and september 2017, a total population of 300 patients underwent gastric plication, 44 patients had a sleeve gastrectomy with endo gia with tri-staple technology and seamguard.It was reported that significant morbidity occurred in eight patients (6.9%) including 4 non-abdominal complications.One patient was reoperated on for hemoperitoneum (0.9%).The female/men ratio was 33/11 with an average age of 42.

• Brand Name: GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT
• Type of Device: 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: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10667438
• MDR Text Key: 215296539
• Report Number: 3003910212-2020-01109
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 42 YR