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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 Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fluid Discharge (2686)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative
No patient specific details have been provided. Therefore, the patient initials reflect the w. L. Gore internal case number. The mean age among the patients was reported to 46. 3 years where the majority of the patents are female. The mean weight was reported 131. 9 kg. The date of incident is unknown. Therefore, the online publication date of the literature article is used as date of incident. Review of the manufacturing records could not be performed as a valid lot number was not provided. Engineering evaluation could not be performed as the device was not returned.
 
Event Description
The literature article: "management of the staple line in laparoscopic sleeve gastrectomy: comparison of three different reinforcement techniques" published by josé manuel fort et al. Was reviewed. The article was published july 1, 2020, in surgical endoscopy. The aim of the article is to compare the complications after laparoscopic sleeve gastrectomy (lsg) with 3 different approaches to the staple line. One of the approach involved using reinforcement with buttress material (bm group), namely the gore® seamguard® bioabsorbable staple line reinforcement. Out of the 100 patients in this group, one patient reported to suffer from a postoperative leak which required reoperation and the placement of an endoluminal stent.
 
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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
ida simson
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12582807
MDR Text Key275009534
Report Number3003910212-2021-01297
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K030782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
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
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/06/2021 Patient Sequence Number: 1
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