• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 06/17/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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: a multicenter randomized controlled trial comparing pancreatic leaks after tissuelink versus seamguard after distal pancreatectomy (plats) nct01051856. Background: pancreatic leak is common after distal pancreatectomy. This trial sought to compare tissuelink closure of the pancreatic stump to that of seamguard. Methods: a multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either tissuelink or seamguard. Results: overall, 67 patients were enrolled, 35 tissuelink and 32 seamguard. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46. 9%) in the seamguard arm and 22 (62. 9%) in the tissuelink arm (p ¼ 0. 19). The trial enrolled patients from january 2010 to march 2014, inclusive. Overall, 58. 2% of patients were female. Median age for the overall cohort was 57 yrs. Fifteen patients experienced leaks, while 4 required a percutaneous drain in the seamguard group.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10241620
MDR Text Key197847087
Report Number3003910212-2020-00112
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043056
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 Received07/07/2020
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? No Answer Provided
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: 07/07/2020 Patient Sequence Number: 1
-
-