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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Fluid Discharge (2686)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

Patient information was requested but no information was provided.Additional information such as date of events, lot/serial numbers were requested, but no information has been provided.The article states: it was noticed that the highest incidence and percentage of bleeding (7.5%; 9 cases) were in the first period, which can be attributed to the early experience and the use of buttress material only over the upper portion of the suture line.After we had started the reinforcement of the whole suture line in june 2014, we had a constant incidence of bleeding, which was 1.7% (4 cases) per year.Note: seamguard was not used in accordance with the ifu in the first period of the study.

Event Description

The following publication was reviewed: perioperative hemorrhagic complications after laparoscopic sleeve gastrectomy: four-year experience of a bariatric center of excellence.Background: bleeding and gastric fistula are the most common postoperative complications after laparoscopic sleeve gastrectomy (lsg).The long stapler line represents the most frequent source of bleeding, which ranges between 0 and 20%.The aim of this retrospective study was to analyze the 4-year experience of a high-volume center with respect to the prevention and management of perioperative lsg bleeding.Methods: the prospectively maintained database from june 2012 to june 2016 was reviewed.Outcomes, especially perioperative bleeding (until patient discharge), its management, and follow-ups, were analyzed.The article reported that two patients developed an infected hematoma which was complicated by a late gastric leak which was treated laparoscopically.

• Brand Name: ENDOSCOPIC GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: cheryl hawke ; 1500 n. 4th street; 9285263030
• MDR Report Key: 10243175
• MDR Text Key: 197944881
• Report Number: 3003910212-2020-00113
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K043056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• 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
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention