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 Problems Hemorrhage/Bleeding (1888); Fluid Discharge (2686)

Event Date 11/30/2012

Event Type  Injury  

Event Description

The following literature publication was reviewed: ¿laparoscopic gastric bypass versus laparoscopic sleeve gastrectomy as a definitive surgical procedure for morbid obesity.Mid-term results¿ the article was published november 30, 2012.Per the article: buttress material was used for staple line reinforcement using gore® seamguard® bioabsorbable staple line reinforcement (seamguard® staple line reinforcement material, w.L.Gore &associates, ariz, usa).Background: laparoscopic sleeve gastrectomy (lsg) has been gaining acceptance because it has shown good shortand mid-term results as a single procedure for morbid obesity.The aim of this study was to compare short- and midterm results between laparoscopic roux-en-y gastric bypass (lrygb) and lsg.Methods: observational retrospective study from a prospective database of patients undergoing lrygb and lsg between 2004 and 2011, where 249 patients (mean age 44.7 years) were included.Results: one hundred thirty-five lrygb and 114 lsg were included.Significant statistical differences between lrygb and lsg were found in operative time (153 vs.93 min.P< 0.001), minor postoperative complications (21.5 % vs.4.4 %, p00.005), blood transfusions (8.8 % vs.1.7 %, p0.Per the article: gastric leak in two, one treated by restapling the leak site and the second by placing an abdominal drain.Two (1.7 %) in the lsg required re-operation because of bleeding.

Manufacturer Narrative

The following literature publication was reviewed: ¿laparoscopic gastric bypass versus laparoscopic sleeve gastrectomy as a definitive surgical procedure for morbid obesity.Mid-term results¿ obes surg (2013) 23:292¿299 doi 10.1007/s11695-012-0828-4 due to an unknown lot/serial number and no device return, an investigation could not be performed.The date of event is unknown, therefore the online publication date of the literature article will be used.Additionally, event information such as item/lot number, implant date, date of explant, patient medical history was requested, however no information has been received.Per the instructions for use (ifu) for the gore® seamguard® bioabsorbable staple line reinforcement, possible adverse reactions may include, but are not limited to: infection, inflammation, adhesions and hematoma.Use of this product in applications other than those indicated has the potential for serious complications.Potential complications include: inadequate reinforcement strength, staple pullout, infection, abrasion, migration and erosion.The use of gore® seamguard® bioabsorbable staple line reinforcement will increase the thickness of the area to be stapled by approximately 0.30 mm.Stapling technique should reflect the thickness of the gore® seamguard® bioabsorbable staple line reinforcement such that the total thickness of material to be stapled falls within the recommended range for the stapler (see stapler instructions for use).Use of staples with insufficient length for the procedure performed may lead to disruption of the staple line due to inadequate staple closure.Use of gore® seamguard® bioabsorbable staple line reinforcement on stapler sizes inconsistent with the product labeling has the potential to cause serious complications.These complications include staple pullout, disruption of the anastomosis and the inability to remove the stapler from the anastomosis after firing.

• 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
• MDR Report Key: 12690516
• MDR Text Key: 282197438
• Report Number: 3003910212-2021-01305
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K030782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 44 YR