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 Death (1802); Necrosis (1971)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

Article citation: gogna, s, et al.¿complex abdominal wall hernia repair with biologic mesh in elderly: a propensity matched analysis.¿ hernia: the journal of hernias and abdominal wall surgery, 2020, pp.10.1007/s10029-019-02068¿7, www.Ncbi.Nlm.Nih.Gov/pubmed/31981009, 10.1007/s10029-019-02068-7.Initial reporter facility name: (b)(6) medical center, school of medicine, (b)(6) medical college.Type of reportable event: serious injury.This mdr is being reported as a multiple event type for serious injury and death.Multiple attempts were made to contact the corresponding author for additional information, including relevant lot numbers and relationship of strattice to the adverse events.To date, no additional information has been obtained.The device was not returned for evaluation and the lot number remains unknown; therefore, internal investigation into the event could not be performed.Based on the reported information, a relationship between the event and strattice cannot be determined.If additional information is reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.

Event Description

Journal article "complex abdominal wall hernia repair with biologic mesh in elderly: a propensity matched analysis" discusses complex abdominal wall reconstruction (cawr) has become a common surgical procedure both in non-elderly and elderly patients.The aim of this study is to analyze the outcomes of the elderly compared to nonelderly undergoing cawr using propensity score matching.All patients who underwent cawr using porcine-derived, non-crosslinked acellular dermal matrix (adm) (strattice¿) between january 2014 and july 2017 were studied retrospectively.Propensity matched analysis was performed for risk adjustment in multivariable analysis and for one-to-one matching.The outcomes were analyzed for differences in postoperative complications, reoperations, mortality, hospital length of stay and adverse discharge disposition.One hundred-thirty-six patients were identified during the study period.Non-elderly (aged 18¿64 years) constituted 70% (n = 95) and elderly (aged = 65 years) comprised 30% of the overall patient population (n = 41).Seventy-three (56.7%) were females.After adjustment through the propensity score, which included 35 pairs, the surgical site infection (p = 1.000), wound necrosis (p = 1.000), the need for mechanical ventilation (p = 0.259), mortality (p = 0.083), reoperation rate (p = 0.141), hospital length of stay (p = 0.206), and discharge disposition (p = 0.795) were similar.Elderly patients undergoing cawr with biological mesh have comparable outcomes with non-elderly patients when using propensity matching score.

Manufacturer Narrative

Clarification to section d.6-strattice grafts were implanted between 2012-2016 corresponding author confirmed the events of death, necrosis and infection were not related to the strattice.

Event Description

Journal article "complex abdominal wall hernia repair with biologic mesh in elderly: a propensity matched analysis" discusses complex abdominal wall reconstruction (cawr) has become a common surgical procedure both in non-elderly and elderly patients.The aim of this study is to analyze the outcomes of the elderly compared to nonelderly undergoing cawr using propensity score matching.All patients who underwent cawr using porcine-derived, non-crosslinked acellular dermal matrix (adm) (strattice¿) between january 2014 and july 2017 were studied retrospectively.Propensity matched analysis was performed for risk adjustment in multivariable analysis and for one-to-one matching.The outcomes were analyzed for differences in postoperative complications, reoperations, mortality, hospital length of stay and adverse discharge disposition.One hundred-thirty-six patients were identified during the study period.Non-elderly (aged 18¿64 years) constituted 70% (n = 95) and elderly (aged = 65 years) comprised 30% of the overall patient population (n = 41).Seventy-three (56.7%) were females.After adjustment through the propensity score, which included 35 pairs, the surgical site infection (p = 1.000), wound necrosis (p = 1.000), the need for mechanical ventilation (p = 0.259), mortality (p = 0.083), reoperation rate (p = 0.141), hospital length of stay (p = 0.206), and discharge disposition (p = 0.795) were similar.Elderly patients undergoing cawr with biological mesh have comparable outcomes with non-elderly patients when using propensity matching score.Follow up with corresponding author confirmed the adverse outcomes were not device related, and that all the strattice grafts remain implanted.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 9934960
• MDR Text Key: 186804027
• Report Number: 1000306051-2020-00017
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention