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); Necrosis (1971); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

Corresponding author.This literature review is being reported as an individual event type as serious injury due to the assumed medical and/or surgical intervention to treat the complications of infection and skin necrosis.The remaining complications of seroma, implant loss and explant, hematoma and implant exposure are not strattice device related serious injuries.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 into the device history records could not be performed.No devices were returned to lifecell for evaluation.A relationship to the strattice could not be determined; however it should be noted that the authors mentioned confounding factors individually and their effects on the outcome of strattice in both cohorts.If additional information is received, a follow up report will be submitted.No further actions are required as a nonconformance could not be confirmed.

Event Description

During a literature review, an article titled "the use of porcine acellular dermal matrix in single-stage, implant-based immediate breast reconstruction: a 2-center retrospective outcome study" was identified that reported a retrospective review of all patients who underwent implant-based breast reconstruction using strattice at university hospital of south manchester (uhsm) and greater manchester and rfh between march 2009 and november 2017.A total of 400 direct-to-implant breast reconstructions were performed on 320 patients (400 breasts) at uhsm and 450 breast reconstructions on 350 patients (450 breasts) at rfh.Complications included major and minor infections, implant loss, skin necrosis, hematoma, implant exposure and seroma.Reported complications per cohort are as follows: uhsm: total complications = 112; major infection = 20; minor infection = 25; implant loss and explant = 8; skin necrosis = 22; hematoma = 15; implant exposure = 5; seroma = 45.Rfh: total complications = 170; major infection = 24; minor infection = 30; implant loss and explant = 10; skin necrosis = 20; hematoma = 18; implant exposure = 8; seroma = 60.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471100
• MDR Report Key: 8091492
• MDR Text Key: 127955083
• Report Number: 1000306051-2018-00142
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• 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: 10/23/2018
• 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
• Treatment: NO INFORMATION
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR