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 05/01/2019

Event Type  Injury  

Manufacturer Narrative

The following literature publication was reviewed: ¿relationship of hemorrhagic complications with perioperative blood pressure in bariatric surgery¿ the article was published in the american surgeon may 2019 vol.85.As the date of event and implant date are unknown, the date of publication will be used may 2019.Due to an unknown lot/serial number and no device return, an investigation could not be performed.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.

Event Description

The following literature publication was reviewed: ¿relationship of hemorrhagic complications with perioperative blood pressure in bariatric surgery¿ the article was published in the american surgeon may 2019 vol.85.Per the article: a retrospective case¿control study, which included patients undergoing either de novo sg or gb between april 2016 and april 2018.All sgs were performed with a bioabsorbable buttressing material (gore® seamguard® bioabsorbable staple line reinforcement w.L.Gore & associates, inc., flagstaff, az) for staple line reinforcement.Of the eight patients who required a reoperation, seven were treated laparoscopically.Twelve hundred three patients underwent sg, with eight (0.67%) developing hc.Two hundred eighty-five patients underwent gb, with three (1.1%) developing hc.There was no difference in the risk of developing hc between the procedures, and for this reason, all additional analysis was completed with the sg and gb patients as one group (p 4 0.93).14 patients either required a reoperation or a blood transfusion.

Manufacturer Narrative

Updated pma/510(k)number.

• 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: 12652370
• MDR Text Key: 281207905
• Report Number: 3003910212-2021-01303
• 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,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• 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: 10/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other