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 Wound Dehiscence (1154); Abscess (1690); Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: npwt - negative pressure wound therapy.Corresponding author.This mdr is being reported as an individual event type as serious injury due to the medical and surgical intervention for the reported surgical site occurrences.It is unclear if any strattice devices were explanted.Multiple attempts were made to contact the corresponding author for additional information, including relevant lot numbers.To date, no additional information has been obtained.The lot numbers associated with these events remain unknown; therefore an internal investigation could not be performed.Based on the reported information, a relationship between the events and the strattice devices cannot be determined.As per the article, 14 of the 15 patients presented with at least one risk factor for surgical site occurrence.No further actions are required; a nonconformance could not be confirmed.If additional information is received, a supplemental report will be submitted.

Event Description

During a literature review, an article titled "complex abdominal wall defect repair using biologic porcine matrix" was identified and reported a retrospective review of patients with complex abdominal wall defect (cawd) who underwent repair with biologic mesh (strattice) between january 2013 and october 2014.A total of 15 patients were included.Strattice was used for hernia repair with primary fascial closure in 12 patients and for bridging of the ab wall defect in 3 patients.Mean age was 67.6±16.6 years old.There were 10 males and 5 females.Comorbidities included diabetes mellitus, active smoking, copd, chronic corticosteroid use, denutrition and obesity.Nine patients had less than 5 pervious abdominal surgeries and six patients had greater than or equal to 5.The 14/15 patients had at least one risk factor for surgical site occurrence.Ten patients presented with at least one postoperative complication during the first 30 days.Seven patients presented with a complication that needed either radiological or surgical intervention, including radiological drainage of an abscess and surgical debridement of parietal necrosis.Six patients were reoperated on during the first three postoperative months, but none required mesh explantation.One patient died during his hospitalization because of postoperative respiratory distress and is determined to be not device related.Specific complications included: 5 infections (abscess), 2 wound dehiscence, 2 enterocutaneous fistulae, 5 hernia recurrence for overall follow up.Conclusions reported that the use of a biologic mesh in contaminated and general complex abdominal fields allows a single stage repair, even if additional small interventions are required for subsequent wound healing and the secondary abdominal wall closure.

• 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: 7704878
• MDR Text Key: 114539651
• Report Number: 1000306051-2018-00092
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• 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: 06/22/2018
• 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: 67 YR