MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MESH, SURGICAL

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

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

March 2012 through june 2016 the reported product is an unknown baxter peri-strips dry with veritas. Initial reporter address - florida international university literature article: gagner, m. , kemmeter, p. ¿comparison of laparoscopic sleeve gastrectomy leak rates in five staple-line reinforcement options: a systematic review¿. Surg endosc. 2020 jan;34(1):396-407. Doi: 10. 1007/s00464-019-06782-2. Epub 2019 apr 16. 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.

Event Description

It was reported 34 patients underwent laparoscopic sleeve gastrectomy¿s in which peri-strips were used. It was reported the patients experienced staple-line leaks following the procedure. It was not reported if the patients were hospitalized for the event. Treatment for the events was not reported. No further details were provided regarding medical interventions or patient outcomes. No additional information is available.

• 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 ; 2242702068
• MDR Report Key: 13048309
• MDR Text Key: 282725222
• Report Number: 1416980-2021-07432
• 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: Literature,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/20/2021 Patient Sequence Number: 1

Treatment

FLOSEAL/TISSEEL; GORE SEAMGUARD; IFABOND OR EVICEL GLUE