MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; MESH, SURGICAL

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

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Nausea (1970); Ulceration (2116); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Date of event: february 2002 to december 2003.The reported product is an unknown baxter peri-strip.Literature article: s.Yu, k.Jastrow, b.Clapp, l.Kao, c.Klein, t.Scarborough, e.Wilson.¿foreign material erosion after laparoscopic roux-en-y gastric bypass: findings and treatment¿.Surg endosc (2007) 21: 1216¿1220; doi: 10.1007/s00464-007-9328-3.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported 153 patients underwent a two-year study in which peri-strips were used with laparoscopic roux-en-y gastric bypass.Six patients experienced post-operative events with incidence of foreign material erosion into the gastric pouch.One patient experienced a gastro-jejunal anastomotic leak and was ¿treated conservatively¿.Three patients experienced strictures, four patients experienced marginal ulcerations, 13 patients experienced nausea, 12 patients experienced vomiting, three patients experienced melena, five patients experienced dysphagia and 15 patients experienced abdominal pain.Treatment for the events was not reported.The study reported the ¿patient outcomes were determined by resolution of symptoms, improvement of symptoms, or no effect or worsening of symptoms at follow-up¿ (no further details).No additional information is available.

Manufacturer Narrative

Additional information: the device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9888535
• MDR Text Key: 185225152
• Report Number: 1416980-2020-01775
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2020
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: NON-BAXTER SILK SUTURE
• Patient Outcome(s): Other