(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.Results of evaluation: no results available since no evaluation performed.The lot associated with this event remains unknown; therefore a review of the device history records could not be performed.Evaluation conclusion: device not returned.Device failure related to patient condition.This literature review is being reported in an abundance of caution as serious injury due to the reported death secondary to sepsis and respiratory failure complications with the use of strattice mesh which may be treated with surgical intervention.Lifecell made multiple attempts to gather additional patient and procedure specific information, including the lot number and device disposition, however no additional information has been received.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.If additional information is reported, a follow up report will be submitted.
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During a literature review performed on 10/05/2017, 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 #14 in table 1 of the article implanted with strattice.Patient #14 was (b)(6) old with a prior diagnosis of omphalocele.Primary skin closure was not achieved following ab wall reconstruction with strattice.Complication reported was patient death from sepsis and respiratory failure.
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