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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL LARGE CURVED SHAPE FOR STRATTICE, (CONTOUR3 FOR EU) MESH, SURGICAL

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LIFECELL LARGE CURVED SHAPE FOR STRATTICE, (CONTOUR3 FOR EU) MESH, SURGICAL Back to Search Results
Catalog Number CON3001EU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Necrosis (1971); Seroma (2069)
Event Date 02/23/2016
Event Type  Injury  
Manufacturer Narrative
The actual device was not returned for evaluation. It was not specified if the strattice device was fully explanted. As per the ifu, potential adverse events are those typically associated with surgical mesh materials and/or their implantation procedures including, but not limited to, infection, lack of tissue perfusion, hematoma and seroma. Multiple attempts are being made to gather additional patient and procedure specific information, including the relevant strattice lot number and device disposition from the corresponding author. A follow up report will be filed with any additional information received and lifecell's conclusion.
 
Event Description
During a monthly post market surveillance literature review, an article titled "innovative management of implant exposure in adm/implant-based breast reconstruction with negative pressure wound therapy" was identified which reported a case report of a (b)(6), brca1-mutated woman who underwent direct to implant breast reconstruction with strattice acellular dermal matrix and a silicone implant two years after a previous contralateral nac-sparing mastectomy and immediate implant-based reconstruction for a triple-negative breast cancer. This event was not reported to lifecell at the time of the occurrence by the surgeon as a complaint against the strattice adm. Seven days after the surgical procedure, the patient presented with significant swelling of the operated breast, with cutaneous signs of haematoma and a five-centimetre area of skin necrosis on the lateral and lower side of the wound. Ultrasound-guided drainage of the seroma/haematoma yielded 200 cc of serous fluid and dark blood, which was positive for staphylococcus hominis. The patient underwent targeted antibiotic therapy and after chemical debridement of the skin necrosis, the implant surface was exposed with the adm partially detached from the inframammary fold. The complication was then managed with staged negative pressure wound therapy until cultures were negative, with four visits to the operating theatre in 3 weeks. The patient was then implanted with a new implant without adm use and final closure of the wound.
 
Event Description
This is a follow up #1 to report additional event information and investigation conclusion. Clinical follow up was provided by the corresponding author on 02/mar/2018. The patient was (b)(6) years old at the time of surgery. Following the previous right side nac-sparing mastectomy and implant-based reconstruction, the patient underwent chemotherapy and post-mastectomy right side radiotherapy; however did not undergo radiotherapy on the left side. The patient was implanted with strattice lot sp100184-279 on (b)(6) 2016. Complications began on (b)(6) 2016. The strattice was fully explanted together with the implant when first positioning the negative pressure wound therapy on (b)(6) 2016. As initially reported: during a monthly post market surveillance literature review, an article titled "innovative management of implant exposure in adm/implant-based breast reconstruction with negative pressure wound therapy" was identified which reported a case report of a (b)(6) year old, brca1-mutated woman who underwent direct to implant breast reconstruction with strattice acellular dermal matrix and a silicone implant two years after a previous contralateral nac-sparing mastectomy and immediate implant-based reconstruction for a triple-negative breast cancer. This event was not reported to lifecell at the time of the occurrence by the surgeon as a complaint against the strattice adm. Seven days after the surgical procedure, the patient presented with significant swelling of the operated breast, with cutaneous signs of haematoma and a five-centimetre area of skin necrosis on the lateral and lower side of the wound. Ultrasound-guided drainage of the seroma/haematoma yielded 200 cc of serous fluid and dark blood, which was positive for staphylococcus hominis. The patient underwent targeted antibiotic therapy and after chemical debridement of the skin necrosis, the implant surface was exposed with the adm partially detached from the inframammary fold. The complication was then managed with staged negative pressure wound therapy until cultures were negative, with four visits to the operating theatre in 3 weeks. The patient was then implanted with a new implant without adm use and final closure of the wound.
 
Manufacturer Narrative
Evaluation included a review of information as reported to lifecell and a review of the device history records associated with lot sp100184. Results of evaluation: qa investigation into lot sp100184 resulted in no remarkable findings with no related deviations or nonconformances revealed during processing. Although one similar complaint associated with seroma and infection was reported against the lot, the event was associated with different organisms and was determined to be highly unlikely related to the strattice. As of 19/mar/2018, of the (b)(4) devices released to finished goods for lot sp100184, (b)(4) devices have been distributed. Lot sp100184 was terminally sterilized and met all qc release criteria. Conclusion: known inherent risk of device the explanted strattice device was not returned to lifecell for evaluation. Based on the results of the internal investigation into lot sp100184, a relationship between the strattice and this event cannot be conclusively determined. It should be noted that coagulase-negative staphylococci such as staphylococcus hominis represent a group of opportunistic microorganisms commonly associated with infections of immunocompromised patients. In addition, wound necrosis is a documented wound healing complication associated with implant-based breast reconstruction with or without the use of an adm (acellular dermal matrix). Multiple factors may contribute to wound healing complications including surgical technique, tissue quality (poorly vascularized tissue), thinness of mastectomy flaps and post operative wound management. Tissue necrosis is most commonly related to inadequate perfusion of breast tissue after mastectomy or after reconstruction and patient risk profile. As per the ifu, potential adverse events are those typically associated with surgical mesh materials and/or their implantation procedures including, but not limited to, infection, lack of tissue perfusion, hematoma and seroma. No further actions are required, a device nonconformance could not be confirmed. As initially reported: corresponding author and associated institution. The actual device was not returned for evaluation. It was not specified if the strattice device was fully explanted. As per the ifu, potential adverse events are those typically associated with surgical mesh materials and/or their implantation procedures including, but not limited to, infection, lack of tissue perfusion, hematoma and seroma. Multiple attempts are being made to gather additional patient and procedure specific information, including the relevant strattice lot number and device disposition from the corresponding author. A follow up report will be filed with any additional information received and lifecell's conclusion.
 
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Brand NameLARGE CURVED SHAPE FOR STRATTICE, (CONTOUR3 FOR EU)
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
MDR Report Key7300020
MDR Text Key101065512
Report Number1000306051-2018-00029
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2016
Device Catalogue NumberCON3001EU
Device Lot NumberSP100184
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/27/2018 Patient Sequence Number: 1
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