MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL VERITAS; MESH, SURGICAL

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2009 to (b)(6) 2014.Chang, craig g.,thackeray, lisa.¿laparoscopic hiatal hernia repair in 221 patients: outcomes and experience¿.Journal of the society of laparoendoscopic surgeons, (january¿march 2016): volume 20 issue 1 e2015.00104.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient underwent a laparoscopic hiatal hernia repair to reduce and/or alleviate gastroesophageal reflux disease (gerd) symptoms and associated hiatal recurrence in which veritas was used as a biologic mesh re-enforcement.Veritas was placed over the cruroplasty, which was previously sutured using braided polyester sutures, and was used to strengthen the repair.This was then sutured to the diaphragm at multiple points using interrupted 0 vicryl sutures.The surgery was performed using an onlay technique (of the biological mesh).Post operatively, the patient developed a leak after sleeve gastrectomy with simultaneous laparoscopic hiatal hernia repair; however, mesh removal was not necessary.The cause of the event was not specified.It was reported the sleeve leak was ¿treated with esophageal stents and percutaneous drainage and resolved uneventfully¿.No additional information is available.

Manufacturer Narrative

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

• Brand Name: VERITAS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE - SAINT PAUL; saint paul MN
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8188974
• MDR Text Key: 131134168
• Report Number: 1416980-2018-07961
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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
• Date Manufacturer Received: 01/17/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention