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

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

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

Patients meeting the inclusion criteria were over the age of 18.2009 and 2010.(b)(6).Mehrdad, mark, m., meininger, michael s.And lacey, martin s.¿veritas bovine pericardium for immediate breast reconstruction:a xenograft alternative to acellular dermal matrix products¿.Eur j plast surg, doi 10.1007/s00238-012-0736-9 (apr-may 2012).

Event Description

It was reported that over a 24-month period 54 patients underwent 93 immediate breast reconstructive procedures following a standardized technique where veritas as a pectoral expander was used.Following surgery where veritas matrix was utilized, seven events of seroma and six surgical site infections were experienced.Prophylactic intravenous antibiotic use and intraoperative antibiotic irrigation with bacitracin solution for tissue expanders and implants was recorded for all patients.An unreported number of patient required inpatient hospitalization and/or implant removal for major infections and an unreported number of patients with minor infections required outpatient oral antibiotic treatment.At the time of this report, the patient outcomes were not reported.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.

• Brand Name: VERITAS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• 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: 7986555
• MDR Text Key: 124398878
• Report Number: 1416980-2018-06662
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• 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: 11/29/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention