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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR MEDIUM; MESH, SURGICAL
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LIFECELL ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR MEDIUM; MESH, SURGICAL Back to Search Results
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 "half there".This complaint is associated with the first of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00165 for the second device implanted with this patient.
 
Event Description
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 "half there".This complaint is associated with the first of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00165 for the second device implanted with 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.
 
Manufacturer Narrative
Pathology was performed at lifecell by dr.Bette lazzaro for this sample.Pathology report c-1198 was completed on 01/mar/2019 and reports: a core/strip of acellular collagen graft material is seen, with a fibrous border at each longitudinal edge.A few scattered mononuclear cells are seen with fibrous borders, but not within the central acellular graft material.Sma (smooth muscle actin) is positive in the cells within the fibrous borders, consistent with myofibroblastic origin.Cd68 is also focally positive within the borders, consistent with macrophage origin.Cd31 vascular marker is negative; trichrome for connective tissue is diffusely positive.Based on the updated event information, this complaint is no longer a reportable event as no device serious injury or malfunction was reported for seroma and capsular contracture.The device remains implanted.
 
Event Description
This is a follow up #3 to report corrected information received from the surgeon on 06/feb/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, lot number and surgery date information was received on 06/mar/2019 from the surgeon and a secondary pathology report was performed by lifecell for the contract lab sample.This patient was implanted with artia lot number up100026-010 on 17/aug/2016.On 07/mar/2019, following a review of the patient's records, the surgeon reported corrected information that this patient developed a seroma and capsular contracture.This patient did not have an extrusion as originally reported.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 1000306051-2018-00165.Refer to b6.As reported in 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.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 "half there".This complaint is associated with the first of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00165 for the second device implanted with this patient.
 
Manufacturer Narrative
Ref d10: 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 have advanced integration after implantation for approximately 3 months.Based on the limited information, including no identification of the lot number, a relationship between the event and the artia could not be determined; however the device performed as expected.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 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 1000306051-2018-00165.Refer to b6.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 "half there".This complaint is associated with the first of 2 devices implanted in this patient.Refer to medwatch 1000306051-2018-00165 for the second device implanted with this patient.
 
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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 Key8217862
MDR Text Key132203086
Report Number1000306051-2018-00164
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K142326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2016
Device Catalogue NumberCM1097
Device Lot NumberUP100026
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NO INFORMATION.; NO INFORMATION.; NO INFORMATION.
Patient Outcome(s) Required Intervention;
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