MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS VERITAS; MESH, SURGICAL

Catalog Number RM0818

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

Patient Problem Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

This report is associated with manufacturer report number 1416980-2016-08360.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced complete resorption of veritas which caused a seroma, after undergoing a surgery in which veritas was used.The resorption was further described as ¿bottoming out of the implant¿ which required revision surgery.The patient had undergone breast reconstruction surgery.The implants were placed partially under the pectoralis major muscle with veritas used to cover the lower pole of the implant and sutured to the pectoralis major muscle superiorly to hold the detached end of the muscle in position and to the chest wall inferiorly and laterally.Subsequently, on return to the surgical theatre for the expander removal and insertion of the final implant, the surgeon noted that there was no veritas and/or no integration of lower pole, the veritas collagen matrix was dissolved leaving only a yellow, gel-like seroma in the implant cavity.This required the patient to undergo revision surgery (date unspecified).No further detail was provided regarding the patient¿s outcome from the event.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VERITAS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; 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: 7437831
• MDR Text Key: 105721493
• Report Number: 1416980-2018-02208
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RM0818
• Device Lot Number: SPCE314-11K0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• 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
• Treatment: MONOFILAMENT SUTURES(2-0)
• Patient Outcome(s): Required Intervention