MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 09/17/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot associated with this event is unknown; therefore a review of the device history record cannot be performed.Lifecell is attempting to gather patient and procedure specific information including the lot number and device disposition and will be included in a follow up report.

Event Description

Subject (b)(6) is a female, as part of the investigator initiated clinical study (lohmander - immediate breast reconstruction with or without the use of acellular dermal matrix (strattice tm) - a randomized controlled trial).This is not a lifecell sponsored study.It was reported that subject (b)(6) was implanted with a strattice pliable device (implant date and lot number not reported) and developed a hematoma (sae start date: (b)(6) 2014) that was evacuated in the or.Sae outcome was reported as "resolved." as the manufacturer, lifecell is reporting this event due to the investigator's assessment that the serious adverse event is possibly related to the study device.

Manufacturer Narrative

This is a follow up #1 to report the associated hospital information and investigation conclusion.Lifecell has made multiple attempts to gather additional information from the investigator; however no additional information has been received to date, including the relevant lot number(s).The lot associated with this event remains unknown; therefore a review of the device history records cannot be performed.As per the risk management file for porcine tissue, it is concluded that hematoma is not caused by porcine tissue surgical mesh.Due to the lack of relevant clinical information and without an associated lot number, no relationship to the device can be determined.As reported in dr.(b)(6)'s abstract, it was concluded that there was no statistical difference regarding overall complications between the study arms.It should also be noted that while dr.(b)(6)'s assessment of the device relationship was "possibly," he reported that he couldn't say with certainty either way.As per the ifu, potential adverse events are those typically associated with surgical mesh materials and/or their implantation procedures including, but not limited to, hematoma.

Event Description

A study abstract published by the site investigator, dr.(b)(6), was reviewed.The abstract reported that this was a randomized multicenter trial primarily in (b)(6) and one site in the (b)(6) with women who had breast cancer planned for immediate ibbr.Subjects were randomly allocated with an adm (strattice) and partial muscle coverage or complete muscle coverage without adm.There were a total of 60 subjects in each arm.The study concluded in (b)(4) 2017.No additional information specific to this event was identified in the abstract.

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; one millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 6969604
• MDR Text Key: 90001470
• Report Number: 1000306051-2017-00082
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• 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: BREAST IMPLANTS
• Patient Outcome(s): Required Intervention