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

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.

Event Description

N/a.

Manufacturer Narrative

There was no product returned for this complaint therefore, failure analysis could not be performed and root cause is indeterminable.No lot number was provided in the complaint documentation, therefore dhr review could not be conducted.

• Brand Name: SURGIMEND MATRIX - UNSPECIFIED
• Type of Device: N/A
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA 02127
• MDR Report Key: 8214868
• MDR Text Key: 132042832
• Report Number: 3004170064-2019-00005
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K071807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-SURGIMEND
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1