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 09/15/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: this event is being reported for the medical intervention to treat the late onset infected seroma.The report of patchy areas of incorporation at the time of exchange is an incidental finding.The device remains implanted and has not been returned for evaluation.Based on limited information, including no identification of the relevant lot number, a relationship between the event and the artia could not be determined.Due to lack of information, artia as a contributing factor cannot be ruled out.Multiple attempts to obtain additional information are being made, including the identification of the lot number.To date, the lot number associated with this event remains unknown; therefore an internal investigation into the device history records could not be performed.Should additional information be reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.

Event Description

It was reported that a patient underwent a right side pre-pectoral unilateral reconstruction with two artia devices on (b)(6) 2017.On (b)(6) 2017, patient underwent exchange where the artia was noted intra-op to have areas of patchy incorporation.On (b)(6) 2018, patient underwent a right nipple-areola reconstruction.The following month on (b)(6) 2018, patient developed red breast and a late onset infected seroma.Patient was placed on antibiotics and drain placed for 4 weeks and seroma resolved.Cultures of seroma fluid were negative.Patient is currently ok.The artia devices are still in place.This complaint is associated with the first of 2 devices implanted on the right side in this patient.Refer to medwatch 1000306051-2018-00158 for the second device implanted in this patient.

Event Description

This is a follow up #1 to report updated information received on 04/jan/2019 and 07/jan/2019.The patient underwent a sub-pectoral reconstruction with one artia device, lot up100105-01.As reported in the initial: it was reported that a patient underwent a right side pre-pectoral unilateral reconstruction with two artia devices on (b)(6) 2017.On (b)(6) 2017, patient underwent exchange where the artia was noted intra-op to have areas of patchy incorporation.On (b)(6) 2018, patient underwent a right nipple-areola reconstruction.The following month on (b)(6) 2018, patient developed red breast and a late onset infected seroma.Patient was placed on antibiotics and drain placed for 4 weeks and seroma resolved.Cultures of seroma fluid were negative.Patient is currently ok.The artia devices are still in place.This complaint is associated with the first of 2 devices implanted on the right side in this patient.Refer to medwatch 1000306051-2018-00158 for the second device implanted in this patient.

Manufacturer Narrative

Qa investigation into lot up100105 resulted in no remarkable findings including 38 devices distributed with no similar complaints against the lot and no related deviations or nonconformances revealed during processing.Lot up100105 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.

• 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: 8217747
• MDR Text Key: 132091096
• Report Number: 1000306051-2018-00156
• 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: 01/31/2019
• Device Catalogue Number: CL1097
• Device Lot Number: UP100105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2019
• 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