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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE SURGICAL MESH

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LIFECELL CORPORATION STRATTICE SURGICAL MESH Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Erythema (1840); Hematoma (1884); Necrosis (1971); Seroma (2069); Post Operative Wound Infection (2446)
Event Date 05/12/2017
Event Type  Injury  
Manufacturer Narrative
Establishment name - (b)(6). This literature review is being reported as an individual event type for the serious injuries reported with the use of strattice mesh, including hospitalization and medical and surgical intervention. Lifecell is attempting to gather lot number information per patient; however it has not been received. If additional information is reported, a follow up report will be submitted. Based on the limited information and without any associated lot number information, a relationship between the events and the strattice cannot be conclusively determined. As reported in the literature review, although strattice was associated with higher rates of skin erythema post-operatively, analyzed per woman or per breast, there was no statistically significant difference in rates of hematoma, infection, wound dehiscence, skin necrosis or seroma. In addition, the study reported that there was statistically significant higher mastectomy breast weight in the strattice group, a recognized risk factor for higher complication rates.
 
Event Description
During a literature review, a publication titled "a direct comparison of porcine (strattice¿) and bovine (surgimend¿) acellular dermal matrices in implant-based immediate breast reconstruction" reported that a retrospective study of sequential experience of immediate ibbr using strattice or surgimend adm to directly compare early outcomes of porcine (strattice¿) and bovine (surgimend¿) adms in ibbr (implant based breast reconstruction) was performed. Data was collected for patients undergoing adm assisted ibbr after prophylactic or therapeutic mastectomy in (b)(6) (october 2011-march 2016). Strattice was used in 19 women (25%, 30 breasts) - 1 patient in october 2011 and 18 patients from april 2013 to april 2014. Patient demographics were collected including age at the time of surgery, bmi, smoking status, co-morbidities, neo adjuvant/adjuvant chemotherapy and radiotherapy. The mean age of women with strattice in the study was 44 years. Oncological treatment was the most common indication in both groups, 13 (68%) in the strattice group. A minimum of three months' follow up from the date of surgery was attained for each patient. Data was collected on rates of erythema or "red breast syndrome", skin necrosis, infection, seroma formation, haematoma and return to theatre for revision surgery. Post-operative outcomes specific to strattice reported that: three breasts reconstructed with strattice had hospital readmission for a complication and two required a return for revisional surgery (no implants were removed). Three breast infections with strattice that were either treated with oral antibiotics or admission for iv antibiotics (exact number of patients not specified). Two hematomas with strattice which required return to theatre for evacuation. One minor wound dehiscence with strattice that was treated conservatively. Four cases of skin necrosis, two of which required hospital admission for revisional surgery (not specified if with strattice). Seven women developed breast seroma, five of which were aspirated as outpatients (not specified if with strattice); eight women had breast skin erythema thought to be adm related - all treated conservatively not requiring any other intervention (not specified if with strattice). Key results reported that strattice was associated with higher rates of skin erythema post-operatively (16. 7% versus 4. 5%). Analyzed per woman or per breast, there was no statistically significant difference in rates of hematoma, infection, wound dehiscence, skin necrosis or seroma, although there was a trend towards more complications with strattice in ibbr. In addition, the study reported that there was statistically significant higher mastectomy breast weight in the strattice group, a recognized risk factor for higher complication rates.
 
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Brand NameSTRATTICE
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
LIFECELL CORPORATION
one millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
one millennium way
branchburg, NJ 08876
9089471470
MDR Report Key6917755
MDR Text Key88724297
Report Number1000306051-2017-00070
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 09/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/05/2017 Patient Sequence Number: 1
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