MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number UNKNOWN

Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)

Patient Problem Bacterial Infection (1735)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method of evaluation: actual device not evaluated - the device was not returned for evaluation.It was not specified if the device was explanted along with the implant.The lot associated with this event remains unknown; therefore a review of the device history records could not be performed.Device not returned.Device failure related to patient condition.Based on the limited information, a relationship between the event and the strattice device could not be determined.The event is likely related to patient condition and unlikely related to strattice.As the literature review reveals, in 22 out of 23 of these cases, the wounds were considered at least contaminated prior to mesh closure.It should be noted that disintegration of the device is not a malfunction when the device is exposed to deleterious substances such as bacterial contamination, or interstitial fluids.Exposure of the device to these substances may be caused by iatrogenic injury, post operative complications, and co-morbid conditions unrelated to the device itself.If additional information is reported, a follow up report will be submitted.

Event Description

During a literature review performed on (b)(6) 2017, a publication titled "the biologic prosthesis is a viable option for abdominal wall reconstruction in pediatric high risk defects" reported that a retrospective chart review was performed of all cases of abdominal wall reconstruction in a single institution (children's hospital los angeles) between january 2007 - february 2015.Overall there were a total of 23 patients who underwent abdominal wall reconstruction using a biological prosthesis including 17 neonates (0-28 days old) and non-neonates (6wks to 19 years).In 22 cases, the wounds were considered at least contaminated or infected prior to mesh closure.This complaint is associated with patient #13 in table 1 of the article implanted with strattice.Patient #13 was(b)(6) with a diagnosis of omphalocele.Primary skin closure was not achieved following ab wall reconstruction with strattice.Complication reported was sloughed mesh and reherniation.

Manufacturer Narrative

Method of evaluation: actual device not evaluated.The device was not returned for evaluation.It was not specified if the device was explanted.

Event Description

No new information was reported.

• 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: 6998894
• MDR Text Key: 90965891
• Report Number: 1000306051-2017-00083
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• 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: 10/05/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 7 DA