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 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 first of 2 devices implanted in this patient.

Manufacturer Narrative

Qa investigation into lot up100026 resulted in no remarkable findings including (b)(4)devices distributed with no similar complaints reported against the lot and no related deviations or nonconformances revealed during processing.Lot up100026 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.

Event Description

This is a follow up #4 to provide device history record review for lot up100026 and investigation conclusion.As reported in follow up #3: this is a follow up #3 to report corrected information received from 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 this mdr.In addition, on (b)(6) 2019 the surgeon confirmed that the patient associated with biopsy sample (2-27-glas) did not experience a complication or adverse event as originally reported.The biopsy was taken to observe integration/performance and is not related to the reported complaint.The patient who did have the extrusion adverse event was implanted with artia lot up100026-017 on (b)(6) 2016.There is no biopsy samples associated with this patient.As reported in follow up #2: 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 17/jan/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 1000306051-2018-00163.Refer to relevant tests/lab data.As reported in follow up #1: this is a follow up #1 to correct the aware date.The surgeon stated the extrusion event was reported approximately 14 months ago to an allergan employee, however no record could be identified.The employee who facilitated the biopsy specimen and who was allegedly made aware of this event is no longer an allergan employee.In the absence of confirming with the former employee, the aware date has been updated to reflect october 2017 in an abundance of caution.To date, no new event information has been provided.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 first of 2 devices implanted in this patient.

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 17/jan/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 1000306051-2018-00163.Refer to relevant test and 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 first of 2 devices implanted in this patient.As reported in the follow up #1: this is a follow up #1 to correct the aware date (g4).The surgeon stated the extrusion event was reported approximately 14 months ago to an allergan employee, however no record could be identified.The employee who facilitated the biopsy specimen and who was allegedly made aware of this event is no longer an allergan employee.In the absence of confirming with the former employee, the aware date has been updated to reflect october 2017 in an abundance of caution.To date, no new event information has been provided.

Manufacturer Narrative

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 #3 to report corrected information received from 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 this mdr.In addition, on (b)(6) 2019 the surgeon confirmed that the patient associated with biopsy sample (b)(6) did not experience a complication or adverse event as originally reported.The biopsy was taken to observe integration/performance and is not related to the reported complaint.The patient who did have the extrusion adverse event was implanted with artia lot: up100026-017 on (b)(6) 2016.There is no biopsy samples associated with this patient.As reported in follow up #2: 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 1000306051-2018-00163.Refer to relevant tests/laboratory data.As reported in follow up #1: this is a follow up #1 to correct the aware date, rec¿d by mfr.The surgeon stated the extrusion event was reported approximately 14 months ago to an allergan employee, however no record could be identified.The employee who facilitated the biopsy specimen and who was allegedly made aware of this event is no longer an allergan employee.In the absence of confirming with the former employee, the aware date has been updated to reflect october 2017 in an abundance of caution.To date, no new event information has been provided.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 first of 2 devices implanted in this patient.

Manufacturer Narrative

Lot number information was received on 06/mar/2019; therefore a review of the device history records for lot: up100026 is on-going.Findings will be submitted in a follow up adverse event report.

Event Description

This is a follow up #1 to correct the aware date (g4).The surgeon stated the extrusion event was reported approximately 14 months ago to an allergan employee, however no record could be identified.The employee who facilitated the biopsy specimen and who was allegedly made aware of this event is no longer an allergan employee.In the absence of confirming with the former employee, the aware date has been updated to reflect (b)(6) 2017 in an abundance of caution.To date, no new event information has been provided.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 first of 2 devices implanted in this patient.

Manufacturer Narrative

As per event, this is a follow up #1 to correct the aware date.To date, no new event information has been provided.

• 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: 8155465
• MDR Text Key: 130254383
• Report Number: 1000306051-2018-00151
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/08/2019

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: 10/31/2016
• Device Catalogue Number: CM1097
• Device Lot Number: UP100026
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 10/01/2017; 01/17/2019; 02/06/2019; 03/18/2019
• Supplement Dates FDA Received: 01/07/2019; 01/30/2019; 03/09/2019; 03/18/2019
• 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