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

Catalog Number RM1225

Device Problem Split (2537)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Ischemia (1942)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that a patient developed wounds on bilateral surgical scars which became infected and were opening exposing implants post a surgery in which veritas had been used.The patient had undergone a skin sparing mastectomy with tissue expander and veritas reconstruction.The expander was placed sub-muscularly and the veritas was in the pockets.Post-operatively, he patient progressed well for about 4-5 weeks, however, the patient did have what appeared to be some relative ischemia of the wound edges.It was reported that the mastectomy wound separated and the implant was in view.On that same day, the patient was taken to the surgical theatre and the wound was explored.It was noted that the veritas had ¿disappeared just deep to wound¿.The veritas was still present where it had been sutured to lower border of pectoralis major muscle and to the inframamammary fold pocket.The veritas had split and disintegrated over the middle of the implant, yet was found fully intact over the pectoral muscle and ¿lvc¿.The pocket was thoroughly washed out and the remaining veritas explanted, the tissue expander was deflated and repositioned but the lower pole now sits subcutaneously.Both implants were removed and replaced.At the time of this report, the patient has had two rounds of chemotherapy treatment without issue.No additional information is available.

Manufacturer Narrative

(b)(4).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; 2575 university ave. w; saint paul MN 55144
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4681457
• MDR Text Key: 13442331
• Report Number: 1416980-2015-16084
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Catalogue Number: RM1225
• Device Lot Number: SPCE313-07G0079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2014
• 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
• Patient Outcome(s): Required Intervention