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 Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(6).This literature review is being reported as an individual event type in an abundance of caution as serious injury due to the reported reconstruction failures.It is unknown what complications resulted in these failures.It is unknown if the strattice devices were explanted.Multiple attempts are being 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.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 "early complications in cases series in implant-based immediate breast reconstruction with a biological acellular matrix during the learning curve of this technique and using 3 different matrices: a case series of 84 breasts" was identified that reported a retrospective study on patients who underwent ibibr with acellular matrix after skin sparing mastectomy by two plastic surgeons at the breast pathology unit at university hospital vall d¿hebron, barcelona between july 2011 and december 2014.A total of 84 breasts were reconstructed in 71 women (58 unilateral and 13 bilateral).Strattice was implanted in 44 reconstructions.The remaining cases used a non-allergan adm.In the strattice group, 13 cases presented complications, including 4 erythema (red breast), 5 seroma, 8 wound dehiscence, 8 skin flap necrosis and 4 resulted in reconstruction failure.

• 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: 8391016
• MDR Text Key: 137850812
• Report Number: 1000306051-2019-00052
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K070560
• 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
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• 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: 02/08/2019
• 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