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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL Back to Search Results
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.
 
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Brand NameGORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT
Type of DeviceMESH, 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 Key10667438
MDR Text Key215296539
Report Number3003910212-2020-01109
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K043056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
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 Received10/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/12/2020 Patient Sequence Number: 1
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