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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Seroma (2069); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
No strattice devices were returned for evaluation. 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, inflammation, lack of tissue perfusion, hematoma, seroma and failure to integrate. Multiple attempts are being made to gather additional information, including the relevant strattice lot numbers from the corresponding author. A follow up report will be submitted within 30 days with any additional information.
 
Event Description
During a literature review, an article was identified titled "the comparison of strattice and surgimend in acellular dermal matrix-assisted, implant based immediate breast reconstruction". The study was conducted across three hospitals in the (b)(6) from january 2010 to december 2014 with patients who underwent immediate implant-based breast reconstruction with strattice and surgimend adms to compare postoperative outcomes. These events were not reported to lifecell at the time of the occurrence by the surgeons as complaints against the strattice. It should be noted that surgimend is a non-lifecell adm device. This manufacturer's incident report is associated with the strattice complications only. There were eighty-two patients who underwent 97 immediate implant-based breast reconstructions using an adm. Of these, 45 patients received strattice, with 54 devices total. Median age of the strattice group was 49. 1 years and comorbidities in patients were hypertension, ischemic heart disease, asthma, smoker or ex-smoker. There were no differences between groups for age, comorbidities, specimen weight, or implant volume. Drains were used in all strattice cases. Acellular dermal matrix loss was defined as surgical removal of adm because of failure of integration into host tissues at the time of implant removal. Complete postoperative outcomes for the study participants implanted with strattice included undefined postoperative complications, seroma, hematoma, skin flap problems, nipple-areola problems, red breast and infection. The implant loss rate was higher for strattice ( n
=
10, 20 percent), but failed to reach statistical significance. The acellular dermal matrix loss rate was significantly higher in the strattice group (n
=
7, 14 percent). The reoperation rate was also significantly higher in the strattice group (n
=
18, 33 percent). Seroma, wound problems, and infection rates were similar. This mdr is being reported as an individual event type for serious injury due to the medical and surgical intervention, including adm loss, for the post-operative complications in the strattice group. Based on the literature, the strattice as a cause or contributor cannot be ruled out.
 
Manufacturer Narrative
This is a follow up #1 report to provide the clinical follow up with the corresponding author. To date, no clinical details including relevant lot numbers have been provided. Based on the limited information reported and without associated lot numbers, a relationship between the events and the strattice devices could not be determined by lifecell. 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, inflammation, lack of tissue perfusion, hematoma, seroma and failure to integrate.
 
Event Description
Clinical follow up was received by the corresponding author, (b)(6), on 08/mar/2018. (b)(6) reported that he does not work at the hospital trusts involved in this study and will require permission from the hospitals to give any patient related data. The study was conducted across three hospitals namely doncaster royal infirmary, bassetlaw hospital and chesterfield royal hospitals. (b)(6) does not have the associated strattice lot numbers, procedure and explant dates. This information requires permission from the lead consultants. To date, permission has not been provided. (b)(6) also clarified that one sheet of strattice adm was deployed in each breast reconstruction. There were some patients who had more than one complication in the cohort such as seroma and infection and explantation or seroma and delayed wound healing, etc. No further detail of each patient complication was provided. As reported in the initial: during a literature review, an article was identified titled "the comparison of strattice and surgimend in acellular dermal matrix-assisted, implant based immediate breast reconstruction". The study was conducted across three hospitals in the uk from january 2010 to december 2014 with patients who underwent immediate implant-based breast reconstruction with strattice and surgimend adms to compare postoperative outcomes. These events were not reported to lifecell at the time of the occurrence by the surgeons as complaints against the strattice. It should be noted that surgimend is a non-lifecell adm device. This manufacturer's incident report is associated with the strattice complications only. There were eighty-two patients who underwent 97 immediate implant-based breast reconstructions using an adm. Of these, 45 patients received strattice, with 54 devices total. Median age of the strattice group was 49. 1 years and comorbidities in patients were hypertension, ischemic heart disease, asthma, smoker or ex-smoker. There were no differences between groups for age, comorbidities, specimen weight, or implant volume. Drains were used in all strattice cases. Acellular dermal matrix loss was defined as surgical removal of adm because of failure of integration into host tissues at the time of implant removal. Complete postoperative outcomes for the study participants implanted with strattice included undefined postoperative complications, seroma, hematoma, skin flap problems, nipple-areola problems, red breast and infection. The implant loss rate was higher for strattice ( n
=
10, 20 percent), but failed to reach statistical significance. The acellular dermal matrix loss rate was significantly higher in the strattice group (n
=
7, 14 percent). The reoperation rate was also significantly higher in the strattice group (n
=
18, 33 percent). Seroma, wound problems, and infection rates were similar. This mir is being reported due to the medical and surgical intervention, including adm loss, for the post-operative complications in the strattice group. Based on the literature, the strattice as a cause or contributor cannot be ruled out.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
MDR Report Key7324857
MDR Text Key102067826
Report Number1000306051-2018-00033
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 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/08/2018 Patient Sequence Number: 1
Treatment
NONE REPORTED
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