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.

Event Description

This is a follow up #1 to provide device history record review for lot up100097 completed on 14/jan/2019 and investigation conclusion.As reported in the initial: it was reported that a patient underwent a bilateral pre-pectoral breast reconstruction with artia (l: (b)(4), (b)(4); r: (b)(4), (b)(4)) on (b)(6) 2017.On (b)(6) 2018, patient underwent bilateral exchange for implants and the artia appeared fine intraoperatively.In (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.

Manufacturer Narrative

Qa investigation into lot up100097 resulted in no remarkable findings including 42 devices distributed with no similar complaints against the lot and no related deviations or nonconformances revealed during processing.Lot up100097 was terminally sterilized within the process parameters and met all qc release criteria.Based on the results of the investigation, a relationship between the artia and this event could not be determined.It should be noted that the artia device remains implanted and that lot up100097 was also implanted in the right breast with no complications.No further actions are required at this time, as a nonconformance could not be confirmed.

• Brand Name: ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR LARGE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• 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
• 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: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: CL1097
• Device Lot Number: UP100097
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO INFORMATION; NO INFORMATION; NO INFORMATION
• Patient Outcome(s): Required Intervention