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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES CIRCULAR BIOABSORBABLE SEAMGUARD MESH, SURGICAL

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W.L. GORE & ASSOCIATES CIRCULAR BIOABSORBABLE SEAMGUARD MESH, SURGICAL Back to Search Results
Device Problems Fluid Leak (1250); Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 01/01/2014
Event Type  Injury  
Manufacturer Narrative
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
The following publication which mentions gore® seamguard® bioabsorbable staple line reinforcement was reviewed: bioabsorbable staple line reinforcement in restorative proctectomy and anterior resection: a randomized study. Background: anastomotic complications, including leaks, strictures/stenosis, and bleeding, cause considerable mortality and morbidity after colorectal surgery. Methods: this study was conducted at 17 centers in the united states. The 258 patients 123 in the reinforcement group (gore® seamguard® circular bioabsorbable staple line reinforcement) and 135 control subjects underwent surgery for a variety of conditions, but most (n
=
200) were treated for rectal cancer. A double-stapled, circular-stapler anastomosis was performed in all of the patients. The diameter of the circular stapler (28 to 34 mm) was determined by the operating surgeon in each case. Results: five patients in each group were found to have an anastomotic air leak at the time of surgery. Three of the leaks in each group required repair; the other 2 did not.
 
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Brand NameCIRCULAR BIOABSORBABLE SEAMGUARD
Type of DeviceMESH, 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 Key10248903
MDR Text Key198089836
Report Number3003910212-2020-00117
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053200
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
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? No
Event Location No Information
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 Treatment Data
Date Received: 07/09/2020 Patient Sequence Number: 1
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