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

Catalog Number XXX-SURGIMEND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the available information. Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Annals of surgery published:" acellular dermal matrix provides durable long-term outcomes in abdominal wall reconstruction: a study of patients with over 60 months of follow. " background: ventral hernia repair(vhr) is one of the most commonly performed procedures in the united states, but studies assessing the long-term outcomes of vhr using biologic mesh are scarce. Methods: "we conducted a retrospective cohort study of patients who underwent awr using either porcine adm(padm) or bovine adm(badm) from 2005 to 2019. We analyzed the full cohort and a subset of our population with minimum long-term follow-up(ltf) of 5 years. The primary outcome measure was hr. Secondary outcomes were ssos. " results: "we identified a total of 725 awrs (49. 5% padm, 50. 5% badm). Mean age was 69±11. 5 years and mean body mass index was 31±7 kg/m2. Forty-two percent of the defects were clean at the time of awr, 44% were clean-contaminated, and 14% were contaminated/infected. Mean defect size was 180±174 cm2, mean mesh size was 414±203 cm2. Hernia recurred in 93 patients(13%), with cumulative hr rates of 4. 9%, 13. 5%, 17. 3%, and 18. 8% at 1, 3, 5, and 7 years, respectively. There were no differences in hr(p
=
0. 83) and sso(p
=
0. 87) between the two mesh types. Ssos were identified in 27% of patients. In our ltf group (n
=
162), the hr rate was 16%. Obesity, bridged repair, and concurrent stoma presence/creation were independent predictors of hr; component separation was protective against hr. " conclusions: despite its use in complex awr, adm provides durable long-term outcomes with relatively low recurrence rates. Doi: 10. 1097/sla. 0000000000004454.

• 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
• Manufacturer (Section G): TEI BIOSCIENCES INC; 7 elkins street; boston MA 02127
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 10936610
• MDR Text Key: 219321295
• Report Number: 3004170064-2020-00018
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K083898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: XXX-SURGIMEND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/20/2021
• 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