MAUDE Adverse Event Report: LIFECELL ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR LARGE MESH, SURGICAL

Catalog Number CL1097

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Seroma (2069)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: this event is being reported for the medical intervention to treat the late onset infected seroma. The device remains implanted and has not been returned for evaluation. Lot number information was received on 03/jan/2019; therefore, a review of the device history records for lot up100097 is on-going. Findings will be submitted in a follow up adverse event report.

Event Description

It was reported that a patient underwent a bilateral pre-pectoral breast reconstruction with artia (l: (b)(4)) on (b)(6) 2017. On (b)(6) 2018, patient underwent bilateral exchange for implants and the artia appeared fine intraoperatively. In mid-(b)(6) 2018, the patient developed left side red breast and late onset infected seroma. Patient was placed on antibiotics and drain placed for 4 weeks and has resolved. Cultures of seroma fluid were negative. The artia devices are still in place. This complaint is associated with the first of 2 devices implanted on the left side in this patient. Refer to medwatch 1000306051-2018-00160 for the second device implanted in this patient.

• Brand Name: ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR LARGE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471100
• MDR Report Key: 8217793
• MDR Text Key: 132090743
• Report Number: 1000306051-2018-00159
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K142326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/31/2018
• Device Catalogue Number: CL1097
• Device Lot Number: UP100097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/04/2019 Patient Sequence Number: 1

Treatment

NO INFORMATION