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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES ENDOSCOPIC GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 10/01/2015
Event Type  Injury  
Manufacturer Narrative
Patient information was requested but no information was provided. Additional information such as date of events, lot/serial numbers were requested, but no information has been provided. 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: simple versus reinforced cruroplasty in patients submitted to concomitant laparoscopic sleeve gastrectomy: prospective evaluation in a bariatric center of excellence. Background: crural closure in addition to laparoscopic sleeve gastrectomy (lsg) represents a valuable option for the synchronous management of morbid obesity and hiatal defects, providing good outcomes in terms of weight loss and gastroesophageal reflux disease (gerd) symptoms control. The aim of this prospective study was to evaluate the safety and effectiveness of the reinforced cruroplasty during lsg compared with a concurrent group of simple cruroplasty.
 
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Brand NameENDOSCOPIC GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT
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 Key10255430
MDR Text Key202005463
Report Number3003910212-2020-00118
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K043056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2020
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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