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

Catalog Number RM1225

Device Problem Material Rupture (1546)

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

Event Type  Injury  

Event Description

It was reported that a patient experienced wound dehiscence and subsequent infection coincident with the use of veritas.The patient had a bilateral prophylactic skin sparing mastectomy and direct to implant immediate reconstruction.Three weeks post operatively, there was a small wound dehiscence on one breast with an exposed implant.The surgeon referred the patient to a general practitioner to start on antibiotics (dose, route, duration, and frequency not reported) for the event.Two days later, it was noted that the same process was starting on the opposite breast.Within a couple of days, the dehiscence worsened, and the surgeon referred the patient to be admitted to the hospital for wound dressings and antibiotics (intravenously, dose, frequency, and duration not reported) for the event.Two days prior to the receipt of this report, the patient underwent surgery to have the implants removed.During the operation, the surgeon noted the veritas had bilaterally ripped in half, thus exposing the implant, which then eroded the underside of the wound leading to an infection.The implants have been removed and the patient is currently recovering on antibiotics (dose, route, duration, and frequency not reported).No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).On (b)(6) 2015, the patient underwent surgery for mastectomy.Should additional relevant information become available, a supplemental report will be submitted.

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.

• 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: 4646911
• MDR Text Key: 5601090
• Report Number: 1416980-2015-13868
• 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,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: RM1225
• Device Lot Number: SPCE314-04D0064
• 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: 09/22/2014
• 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
• Treatment: ALLERGAN TEXTURED IMPLANTS
• Patient Outcome(s): Hospitalization; Required Intervention