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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Fluid Discharge (2686)
Event Date 11/23/2014
Event Type  Injury  
Manufacturer Narrative
The following literature publication was reviewed: ¿laparoscopic and robotic sleeve gastrectomy: short- and long-term results¿ obes surg (2015) 25:967¿974 doi 10. 1007/s11695-014-1499-0 published online: 23 november 2014 springer science+business media new york 2014. No patient specific details have been provided. Therefore, the patient initials reflect the w. L. Gore internal case number. 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. (b)(4). 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 and robotic sleeve gastrectomy: short- and long-term results¿ the article was published november 23, 2014. Per the article: introduction: sleeve gastrectomy has gained popularity over the past decade due to its safety, feasibility, and good results. The purpose of this study is to describe our results, both short and long term, with this procedure. Material and methods: this study is a nonrandomized, controlled, retrospective review of 409 patients who underwent a minimally invasive sleeve gastrectomy at the university of illinois hospital and health system from january 2008 to december 2013. A total of 304 patients underwent a laparoscopic sleeve gastrectomy, and another 105 patients underwent a robotic procedure using the da vinci surgical system®. Patient demographics, comorbidities, date of surgery, postoperative morbidity and mortality, operating time, length of stay, and excess weight loss were reviewed. Results: the mean age was 41 years (18¿70) with no statistical difference between the two groups. Patient¿s demographics were similar (p
=
0. 395) in both groups. The mean operative time for the robotic group was 110. 6 versus 84. 18 min in the laparoscopic group, which was statistically significant (p<0. 05). There were no significant differences between the two groups with regard to the perioperative complications, length of stay, or % excess weight loss. Conclusion: there is no significant difference between the robotic and laparoscopic group in terms of complications, length of stay, and estimated blood loss. Lsg: the stapler reloads were reinforced using gore® seamguard® bioabsorbable staple line reinforcement (wl gore & associates inc, flagstaff, az). There were two complications in the laparoscopic group: one patient who presented with intraoperative bleeding that required an emergency splenectomy and another patient who had a suture leak on postoperative day 5 that required reoperation, drainage, and a stent placement.
 
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Brand NameGORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT
Type of DeviceMESH, 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 Key12715917
MDR Text Key282965632
Report Number3003910212-2021-01309
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/28/2021 Patient Sequence Number: 1
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