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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/22/2020
Event Type  Injury  
Event Description
The following literature publication was reviewed: gontrand lopez-nava, ravishankar asokkumar, inmaculada bautista-castaño, janese laster, anuradha negi, stephanie fook-chong, javier nebreda duran, eduard espinett coll, jordi pujol gebelli, amador garcia ruiz de gordejuela. Title: endoscopic sleeve gastroplasty, laparoscopic sleeve gastrectomy, and laparoscopic greater curve plication: do they differ at 2 years? published online jun 22, 2020 in endoscopy (endoscopy 2021; 53: 235¿243). From january 2014 to april 2016, data of 61 patients which underwent laparoscopic sleeve gastrectomy (lsg) were collected from belvitge university hospital, barcelona, spain, with the aim of comparing the effectiveness and safety of endoscopic sleeve gastroplasty (esg) with lsg and laparoscopic greater curve plication (lgcp). On all patients operated for lsg, staples reinforced with gore® seamguard® bioabsorbable staple line reinforcement were used. Out of these 61 patients, 2 patients developing hemoperitoneum and required surgery. 1 patient developed mild hemoperitoneum and was treated conservatively without any further intervention.
 
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 44. 6 years where the majority of the patents are female. The average weight was reported 112. 5 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. Literature citation: endoscopy 2021; 53: 235¿243. Per the instructions for use (ifu) for the gore® seamguard® bioabsorbable staple line reinforcement, possible adverse reactions may include, but are not limited to: adhesions, hematoma, infection, and inflammation.
 
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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 Key12779262
MDR Text Key284643290
Report Number3003910212-2021-01311
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 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
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
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/09/2021 Patient Sequence Number: 1
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