MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

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

Patient Problems Unspecified Infection (1930); Prolapse (2475)

Event Date 12/25/2020

Event Type  Injury  

Manufacturer Narrative

Article citation: brunbjerg, mette eline et al.¿reinforcement of the abdominal wall with acellular dermal matrix or synthetic mesh after breast reconstruction with the pedicled transverse rectus abdominis musculocutaneous flap.A prospective double-blind randomized study.¿ journal of plastic surgery and hand surgery, 1-8.25 dec.2020, doi:10.1080/2000656x.2020.1856673.(b)(4).The device was not returned for evaluation and the lot number remains unknown; therefore, internal investigation into the event could not be performed.Based on the reported information, a relationship between the event and strattice cannot be determined.If additional information is reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.

Event Description

Article entitled "reinforcement of the abdominal wall with acellular dermal matrix or synthetic mesh after breast reconstruction with the pedicled transverse rectus abdominis musculocutaneous flap.A prospective double-blind randomized study" was reviewed: introduction: the pedicled transverse rectus abdominis musculocutaneous flap (p-tram) is a well-established option for autologous breast reconstruction (br) but donor-site morbidity is still reported.The aim of the present study was to compare donor-site morbidity after reinforcement of the abdominal wall regarding development of bulging or hernia, abdominal muscle strength, complications, and abdominal pain hypothesizing, that reinforcement with acellular dermal matrix (stratticetm) is superior to reinforcement with synthetic mesh (prolenevr ).Materials and methods: a randomized, prospective, double-blind study was conducted with 29 patients admitted for br with the p-tram flap at department of plastic surgery, auh, denmark, 2014¿2016.Allocation rate 1:1.Follow-up at 4, 12, and 24months.Results: 24months postoperatively the computerized tomography verified bulging frequency was 35.7% in the adm group and 6.7% in the synthetic mesh group (p¼0.11).Two patients (14.3%) in the adm group and no patients in the synthetic mesh group developed hernia.No significant difference between baseline and 2-year measurement of abdominal muscle strength was observed.Conclusion: the present study did not demonstrate any statistically significant differences between treatment groups regarding risk of bulging or hernia, abdominal muscle strength, complications, pain or pain related qol within two years of follow-up.Although the small sample size sets limitations for drawing wide conclusions the hypothesis that reinforcement with adm is superior to synthetic mesh cannot be confirmed.Further research into methods for decreasing donor-side morbidity related to the tram flap or other rectus abdominis muscle-based flaps is needed.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer Contact: michelle burgess ; 1 millennium way; branchburg, NJ ; 9089471470
• MDR Report Key: 11352519
• MDR Text Key: 241564633
• Report Number: 1000306051-2021-00015
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR