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 08/02/2014

Event Type  Injury  

Manufacturer Narrative

The following literature publication was reviewed: ¿laparoscopic sleeve gastrectomy versus laparoscopic roux-en-y gastric bypass: a single center experience with 2 years follow-up¿ obes surg (2015) 25:254¿262 doi 10.1007/s11695-014-1388-6.The date of event is unknown, therefore the date the article was published online august 2, 2014 will be used.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: ¿laparoscopic sleeve gastrectomy versus laparoscopic roux-en-y gastric bypass: a single center experience with 2 years follow-up¿ the article was published online (b)(6) 2014.Per the article: background: laparoscopic sleeve gastrectomy (lsg) is a relatively new procedure that is gaining wide acceptance.However, laparoscopic roux-en-y gastric bypass (lrygb) remains one of the most commonly performed bariatric procedures with the best long-term results.There are few studies comparing lsg with lrygb.The aim of this study is to compare the safety and outcome of lsg to lryg in a single accredited center.Methods: a retrospective analysis of data collected prospectively on patients undergoing either lsg or lrygb between january 2009 and december 2012 was performed.Lsg was performed using 36fr bougie, while lrygb was performed with a 25-mmcircular stapler.The primary outcomes included length of stay (los), 30-day complication and readmission rates, and excess weight loss (%ewl) at 3, 6, 12, and 24 months postoperatively.Lsg patients were also divided into different categories based on bmi and their %ewl compared to lrygb results: a total of 885 patients were included in our analysis.547 patients underwent lrygb (61.8 %) and 338 underwent lsg (38.2 %).Thirty-day complication and readmission rates for lrygb and lsg were (1.5 and 5.1 % vs 0.6 and 0.3 %, respectively, p>0.05).%ewl for lrygb was significantly higher than lsg at 3, 6, 12, and 24 months.Lsg with a bmi<40 achieved a similar %ewl to lrygb in the first 12 months.Conclusions: lsg seems to have a better safety profile in the short-term compared to lrygb.However, at 2 years, lrygb patients achieved a significantly higher ewl compared to lsg patients.Randomized clinical trials are needed to better elucidate our findings.The paper reports they only used a ¿reabsorbable buttressing material¿ in the laparoscopic sleeve gastrectomy (lsg) cases, therefore from table 3, there were 2 cases of bleeding/hemorrhage and 1 bleed requiring re-operation.

• 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: angela brown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12705740
• MDR Text Key: 278823959
• Report Number: 3003910212-2021-01307
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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: 10/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 45 YR