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

Catalog Number CM1097

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Seroma (2069)

Event Date 12/01/2018

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 up100104 is on-going.Findings will be submitted in a follow up adverse event report.

Event Description

It was reported that a patient underwent a right side pre-pectoral breast reconstruction with two artia devices ((b)(4)) on (b)(6) 2018.In early (b)(6) 2018 following chemotherapy, patient developed red breast and a late onset infected seroma.The patient was placed on antibiotics and drain placed for 4 weeks which has resolved.Cultures of seroma fluid were negative.The artia devices are still in place.Patient is scheduled for exchange surgery on (b)(6) 2019.This complaint is associated with the second of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00161 for the first device implanted in this patient.

Event Description

This is a follow up #2 to report additional patient event information reported by the surgeon on 06/mar/2019.Additional information was reported from the surgeon that following the exchange, the patient presented with intense inflammation in right side axilla and artia.As reported in follow up #1: this is a follow up #1 to provide device history record review for lot up100104 completed on 14/jan/2019 and investigation conclusion.As reported in the initial: it was reported that a patient underwent a right side pre-pectoral breast reconstruction with two artia devices (up100104-024, up100104-025) on 20/jul/18.In early (b)(6) 2018 following chemotherapy, patient developed red breast and a late onset infected seroma.The patient was placed on antibiotics and drain placed for 4 weeks which has resolved.Cultures of seroma fluid were negative.The artia devices are still in place.Patient is scheduled for exchange surgery on (b)(6) 2019.This complaint is associated with the second of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00161 for the first device implanted in this patient.

Manufacturer Narrative

Based on the additional information, the investigation results from review of the device history records remain unchanged.A relationship between the artia devices and the patient's on-going complications could not be determined.

Manufacturer Narrative

Qa investigation into lot up100104 resulted in no remarkable findings including 31 devices distributed and no related deviations or nonconformances revealed during processing.Although one similar complaint was reported against the lot, it was associated with the same physician and the same case.Lot up100104 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.No further actions are required at this time, as a nonconformance could not be confirmed.

Event Description

This is a follow up #1 to provide device history record review for lot up100104 completed on 14/jan/2019 and investigation conclusion.As reported in the initial: it was reported that a patient underwent a right side pre-pectoral breast reconstruction with two artia devices ((b)(4)) on 20/jul/18.In early (b)(6) 2018 following chemotherapy, patient developed red breast and a late onset infected seroma.The patient was placed on antibiotics and drain placed for 4 weeks which has resolved.Cultures of seroma fluid were negative.The artia devices are still in place.Patient is scheduled for exchange surgery on (b)(6) 2019.This complaint is associated with the second of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00161 for the first device implanted in this patient.

• Brand Name: ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR MEDIUM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8217847
• MDR Text Key: 132116575
• Report Number: 1000306051-2018-00162
• 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,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: CM1097
• Device Lot Number: UP100104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/14/2019; 03/06/2019
• Supplement Dates FDA Received: 01/30/2019; 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO INFORMATION; NO INFORMATION; NO INFORMATION; NO INFORMATION
• Patient Outcome(s): Required Intervention