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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN STRATTICE MESH, SURGICAL

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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 Bacterial Infection (1735); Necrosis (1971)
Event Type  Injury  
Manufacturer Narrative
Initial reporter: corresponding author and institution. This literature review is being reported as an individual event type in an abundance of caution as serious injury due to the reported complications with intervention. It is unknown if the strattice devices were explanted. Multiple attempts were made to gather additional patient and procedure specific information including lot numbers and device dispositions. To date, the lot numbers associated with these events remain unknown; therefore an internal investigation could not be performed. No devices were returned to lifecell for evaluation. A relationship to the strattice could not be determined. No further actions are required as a nonconformance could not be confirmed. If additional information is received, a follow up report will be submitted.
 
Event Description
During a literature view performed by patient safety operations on 9/20/2021, an article titled "short to medium -term outcome of prepectoral versus subpectoral direct-to-implant reconstruction using acellular dermal matrix" was identified which discussed subpectoral implant reconstruction (sir) is associated with animation deformity and increased postoperative pain. The aim of the study was to compare the short-to medium outcome of prepectoral implant reconstruction (pir) and sir with acellular dermal matrix. A review of prospectively collected data of patients who underwent pir and sir using biological mesh by a single surgeon between november 2016 and november 2020 was performed. Presentation, smoking history, bmi, bra size, radiology size, pathology data, mastectomy weight, implant volume, radiation treatment and outcomes were analyzed. 82 patients had 109 implant reconstructions (85 pir and 24 sir). Median follow up was 27 months. 25 pir and 6 sir were risk reduction surgeries. Two groups were comparable except for significantly higher percentage of node positive, her 2-positive disease, and radiotherapy in sir. There was no statistically significant difference between the two groups with regard to hematoma, wound infection, red reaction, seroma needing aspiration, wound necrosis and implant loss. Significantly more patients in the prepectoral group had rippling needing fat grafting and significantly more patients in the subpectoral group had fat grafting for contour deformity. Three types of biological mesh were used in the subpectoral reconstruction. (strattice and two non-abbvie products) and two types of biological mesh were used in prepectoral reconstruction (both non-abbvie products). All patients had iv co-amoxiclav at induction and were sent home with oral antibiotics. Antibiotics were continued until the drains were in place for a maximum of 2 weeks. Complications listed for the subpectoral group under table 2 "comparison of complications between prepectoral and subpectoral implant reconstruction" listed hematoma, wound infection, red reaction, wound necrosis and overall implant loss. Complications listed for the strattice group under table 5 "comparison of wound problems and implant loss between biological products from three different companies" lists red breast, infection, and wound necrosis. The article reported there were no significant difference in the overall outcome (wound problems and implant loss within 1 year) between the biologicals mesh products of the three different companies used, as shown in table 5. Complications requiring operative intervention were reported in 24 breasts, and minor occurred in 23 breasts. Surgical complications did not different with the type of mesh used, type of incision used, and the use of postmastectomy radiotherapy. The overall conclusion reported that pir is comparable to conventional sir with regard to most of the complications.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
MDR Report Key12641273
MDR Text Key281030872
Report Number1000306051-2021-03066
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
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
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 Received09/20/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/15/2021 Patient Sequence Number: 1
Treatment
IMPLANTS
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