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 Problem Stenosis (2263)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Patient information was requested but no information was provided.The date of event, lot/serial number was also requested, but no information has been provided.As the event date is unknown, the event date reported is the date of the publication.

Event Description

The following publication which mentions gore® seamguard® bioabsorbable staple line reinforcement was reviewed: simple versus reinforced cruroplasty in patients submitted to concomitant laparoscopic sleeve gastrectomy: prospective evaluation in a bariatric center of excellence.Background: crural closure in addition to laparoscopic sleeve gastrectomy (lsg) represents a valuable option for the synchronous management of morbid obesity and hiatal defects, providing good outcomes in terms of weight loss and gastroesophageal reflux disease (gerd) symptoms control.The aim of this prospective study was to evaluate the safety and effectiveness of the reinforced cruroplasty during lsg compared with a concurrent group of simple cruroplasty.Methods: the study groups included 96 morbidly obese patients who underwent simultaneous lsg and cruroplasty.Group a: 48 patients with hiatal areal defect\4 cm2 and normal pillars (simple posterior cruroplasty); group b: 48 patients with hiatal areal defect[4 and\8 cm2 with weakness of the right pillar (on-lay synthetic absorbable mesh-reinforced cruroplasty).Upper gi symptoms were assessed by roma iii standard questionnaire.Endoscopy, imaging, esophageal 24-h ph monitoring and hrmanometry were performed in cases of persistent or recurrent symptoms after surgery.Results: once case of midgastric stenosis occurred that was treated by endoscopic dilation.

• 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: 10244679
• MDR Text Key: 197944238
• Report Number: 3003910212-2020-00116
• 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: 07/08/2020
• 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): Other