MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Necrosis (1971); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 04/13/2017

Event Type  Injury  

Manufacturer Narrative

Ref.Patients were male and female.(b)(4).This literature review is being reported as an individual event type for the serious injuries reported with the use of strattice mesh, including mesh removal and prolonged hospital admission.Lifecell has attempted to gather specific lot number information; however it is unavailable.If additional event specific information is reported, a follow up report will be submitted.Based on the limited information and without any associated lot number information, a relationship between the events and the strattice cannot be conclusively determined.As reported in the literature review, the conclusion was that using biologic mesh, one-quarter and one-fifth of cawr patients are complicated with reoperation or recurrence, respectively.The operation setting and comorbidity play a role in these outcomes regardless of mesh placement techniques.

Event Description

During a literature review performed on 08/31/2017, a publication titled "risk-adjusted adverse outcomes in complex abdominal wall hernia repair with biologic mesh: a case series of 140 patients" reported that a retrospective study was performed on 140 patients who underwent complex abdominal wall hernia repair (cawr) with biologic mesh between 2010 and 2015 at a tertiary medical center (the university of arizona, tucson).Patients were male and female with a mean age of 54 +/- 14 years.The study aimed to identify predictors of adverse outcomes after cawr using biologic mesh with different placement techniques and different surgical settings.The patients had co-morbidities such as alcohol use, bowel obstruction, bowel resection, cancer, cardiac disease, copd, diabetes, smoking, transplant.Strattice was implanted in 82.9% of patients (~116 patients) and a human mesh was implanted in 24 patients.Overall complications with biologic mesh included wound complications (superficial surgical site infections, deep or organ/space infections, seroma formation, wound dehiscence, skin and subcutaneous tissue necrosis) at 30.7%, reoperation at 25.9%, hernia recurrence at 20.7% and mesh removal at 10.0%.Thirty two patients (23.0%) were admitted to the icu and the mean hospital length stay was 10.8 +/- 17.5 days.In addition, four patients died, including two males and two females.Cause of death was reported as: hemodynamic instability and respiratory failure, sepsis, ards and liver failure, heart failure.As reported in the literature review, the conclusion was that using biologic mesh, one-quarter and one-fifth of cawr patients are complicated with reoperation or recurrence, respectively.The operation setting and comorbidity play a role in these outcomes regardless of mesh placement techniques.Urgent repair and the use of porcine mesh were independently associated with higher odds of hernia recurrence.Large hernias, use of porcine mesh and urgent procedures had higher odds of reoperation.In an attempt to gather further information specific to each event, lifecell contacted the corresponding author, dr.(b)(6).As per dr.(b)(6), lot number information is unavailable and specific procedure date information could be obtained.Dr.(b)(6) also reported that strattice was not associated with the four patient deaths; therefore is determined as not a reportable death event.To date, the physician has not provided procedure date information.

• 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: 6903687
• MDR Text Key: 87757825
• Report Number: 1000306051-2017-00069
• 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
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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: 08/31/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR