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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 "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.
 
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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 Key8155465
MDR Text Key130254383
Report Number1000306051-2018-00151
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,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 Date10/31/2016
Device Catalogue NumberCM1097
Device Lot NumberUP100026
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/14/2018
Initial Date FDA Received12/12/2018
Supplement Dates Manufacturer Received10/01/2017
01/17/2019
02/06/2019
03/18/2019
Supplement Dates FDA Received01/07/2019
01/30/2019
03/09/2019
03/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NO INFORMATION; NO INFORMATION; NO INFORMATION; NO INFORMATION
Patient Outcome(s) Required Intervention;
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