MAUDE Adverse Event Report: LIFECELL UNKNOWN ARTIA; MESH, SURGICAL

Catalog Number UNK ARTIA

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

Patient Problems Foreign Body Reaction (1868); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Conclusion: the device 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 as well as clarification of the extrusion.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 who underwent a sub-pec, unilateral reconstruction with two artia devices had extrusion through the inferior pole with redness and inflammation.The patient had no wound healing issues prior.The tissue expander was removed and a biopsy of the artia was taken.The artia that did not incorporate was debrided.It was also reported that the artia was "completely resorbed".This complaint is associated with the second of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00151 for the first device implanted.It should be noted that although the initial event was received on (b)(6) 2018, the additional information regarding two devices was reported by the surgeon on (b)(6) 2018.

Event Description

This is a follow up #2 to report corrected information received by the surgeon on (b)(6)2019 that only 1 artia device was implanted in this patient; therefore there is no complaint against a second device.All relevant event information regarding the implanted device is captured under medwatch 1000306051-2018-00151.As reported in follow up #1: this is a follow up #1 to report biopsy specimen results performed by a non-allergan contract lab.The final results were received by allergan on (b)(6) 2019.It should be noted that it is unknown which implanted artia device was sampled; therefore the results are included in both this mdr as well as mdr 1000306051-2018-00151.Refer to relevant tests/laboratory data.It was reported that a patient who underwent a sub-pec, unilateral reconstruction with two artia devices had extrusion through the inferior pole with redness and inflammation.The patient had no wound healing issues prior.The tissue expander was removed and a biopsy of the artia was taken.The artia that did not incorporate was debrided.It was also reported that the artia was "completely resorbed".This complaint is associated with the second of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00151 for the first device implanted.It should be noted that although the initial event was received on (b)(6) 2018, the additional information regarding two devices was reported by the surgeon on (b)(6) 2018.

Manufacturer Narrative

As reported in event, the surgeon confirmed that the patient was implanted with only 1 artia device; therefore there is no complaint against a second device.

Manufacturer Narrative

Ref concomitant medical products: specimen of the device was evaluated by a contract lab, and not the manufacturer; therefore selected as no.Conclusion: the biopsy specimen reviewed by the contract lab concluded that the artia adm was considered to be minimally integrated after implantation for approximately 3 months.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the artia could not be determined.The device as a contributing factor cannot be ruled out.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 lot number information be reported, a follow up adverse event report will be submitted.

Event Description

This is a follow up #2 to report biopsy specimen results performed by a non-allergan contract lab.The final results were received by allergan on (b)(6) 2019.It should be noted that it is unknown which implanted artia device was sampled; therefore the results are included in both this mdr as well as mdr 1000306051-2018-00151.Refer to relevant tests/laboratory data.As reported in the initial: it was reported that a patient who underwent a sub-pec, unilateral reconstruction with two artia devices had extrusion through the inferior pole with redness and inflammation.The patient had no wound healing issues prior.The tissue expander was removed and a biopsy of the artia was taken.The artia that did not incorporate was debrided.It was also reported that the artia was "completely resorbed".This complaint is associated with the second of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00151 for the first device implanted.It should be noted that although the initial event was received on (b)(6) 2018, the additional information regarding two devices was reported by the surgeon on (b)(6) 2018.

• Brand Name: UNKNOWN ARTIA
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8217858
• MDR Text Key: 132092831
• Report Number: 1000306051-2018-00163
• 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,other
• Type of Report: Initial,Followup,Followup

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 Catalogue Number: UNK ARTIA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• 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