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 03/23/2012

Event Type  Injury  

Event Description

The literature article: ¿staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial¿ published by paolo gentileschi, ida camperchioli, stefano d¿ugo, domenico benavoli and achille l.Gaspari was reviewed.The article was published online on march 23, 2012 in surgical endoscopy (surg endosc (2012) 26:2623¿2629).The purpose of this study was to compare prospectively and randomly three different techniques of staple line reinforcement (slr) during laparoscopic sleeve gastrectomy (lsg).From april 2010 to april 2011, a total of 120 patients were enrolled in this study.Out of these patients, 40 had buttressing of the staple line using gore® seamguard® bioabsorbable staple line reinforcement.1 of these patients suffered from bleeding and was treated with blood transfusions and intensive-care unit observation for 48 hours.

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The mean age among the patients was reported to 44.1 years, the average weight was 145.2 kg where the majority of the patents are female.The date of incident is unknown.Therefore, the online publication date of the literature article is used as date of incident.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.The following literature publication was reviewed: ¿staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial¿ the citation of this article is surg endosc (2012) 26:2623¿2629.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.

Manufacturer Narrative

Updated pma/510(k)number.

Manufacturer Narrative

Updated type of investigation code to: 4119 - insufficient information available.Code 4111 was inadvertently entered, but correct code should be 4119.

• 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: 12677147
• MDR Text Key: 281905316
• Report Number: 3003910212-2021-01304
• 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: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 44 YR
• Patient Weight: 145