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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/20/2008

Event Type  Injury  

Manufacturer Narrative

No patient identifier have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.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: surg obes relat dis.Mar-apr 2015;11(2):296-301.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.

Event Description

The following literature publication was reviewed: carlos rodríguez-otero luppi, carmen balagué, eduard m.Targarona, sorin mocanu, jesús bollo, carmen martínez, and manel trias.Title: laparoscopic sleeve gastrectomy in patients over 60 years: impact of age on weight loss and co-morbidity improvement.Published online jun 2, 2014 in surgery for obesity and related diseases (surg obes relat dis.Mar-apr 2015;11(2):296-301).130 patients underwent laparoscopic sleeve gastrectomy (lsg).On all patients, staples reinforced with gore® seamguard® bioabsorbable staple line reinforcement were used.1 patient required surgical reintervention due to hemoperitoneum.The patient was hemodynamically unstable and required a laparotomy.

Manufacturer Narrative

H6 - code 4111: the author of the article was contacted to provide additional information regarding the adverse events.The author provided patient details as well as prior health conditions.Update component code.

• Brand Name: GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT
• Type of Device: MESH, 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 Key: 12785736
• MDR Text Key: 280577803
• Report Number: 3003910212-2021-01312
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K030782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• 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 Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male