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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND MATRIX - UNSPECIFIED N/A

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TEI BIOSCIENCES INC SURGIMEND MATRIX - UNSPECIFIED N/A Back to Search Results
Catalog Number XXX-SURGIMEND
Device Problem Insufficient Information (3190)
Patient Problems Ischemia (1942); Necrosis (1971)
Event Type  Injury  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
 
Event Description
1 of 2 reports - other mfg report number: 3004170064-2019-00003. The american society of plastic surgeons (2017) published: "bovine acellular dermal matrix in immediate breast reconstruction: a retrospective, observational study with surgimend". Methods: this was a retrospective, single-center analysis of 111 adult patients (147 breasts) undergoing one-stage (83. 7 percent) or two-stage (16. 3 percent) immediate breast reconstruction after mastectomy. The aims were to characterize the safety profile of surgimend and investigate associations between risk factors and complications. Complication: (b)(6) year-old woman with right breast cancer underwent bilateral nipple-sparing mastectomy and immediate, direct-to-implant breast reconstruction with acellular dermal matrix. At 2 months postoperatively, the patient experienced a 3 x 3-cm area of ischemia in the lower outer quadrant that was treated with microfat grafting but evolved into a large, full-thickness necrosis with eminent extrusion. Salvage was undertaken with a laterally based thoracoepigastric flap and exchange to a tissue expander. This solved the problem. Results: the mean age of the patients was 47. 9 years and the mean body mass index was 24. 7 kg/m2. After a median follow-up of 24. 3 months, the overall rates of minor and major complications were 25. 2 percent (n
=
37 of 147) and 12. 9 percent (n
=
19 of 147), respectively. The most common major complications were seroma [n
=
12 (8. 2 percent)] and necrosis [n
=
9 (6. 1 percent)]. All occurred within 3 months after surgery. The rate of capsular contracture was 2. 7 percent (n
=
4). A total of 2. 7 percent of implanted breasts (n
=
4) required explantation. In a univariate analysis, smokers had a greater risk of major complications, and postoperative radiation therapy and obesity were associated with an increased risk of capsular contracture and explantation, respectively. In a multivariate analysis, several factors were associated with complications or explantation, including obesity, preoperative chemotherapy, and mastectomy weight. These associations align with other studies of implant-based reconstruction and do not appear to be specific to this acellular dermal matrix. Conclusion: the results are consistent with previous analyses of surgimend,and support its value in implant-based breast reconstruction.
 
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Brand NameSURGIMEND MATRIX - UNSPECIFIED
Type of DeviceN/A
Manufacturer (Section D)
TEI BIOSCIENCES INC
7 elkins street
7 elkins street
boston MA 02127
Manufacturer (Section G)
TEI BIOSCIENCES INC
7 elkins street
boston MA 02127
Manufacturer Contact
vivian nelson
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8214868
MDR Text Key132042832
Report Number3004170064-2019-00005
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K071807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-SURGIMEND
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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