MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Septic Shock (2068); Seroma (2069)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

Method of evaluation: actual device not evaluated; the complaint related device was not returned to lifecell for evaluation.Based on the reported information, it is unknown if the device was explanted.Results of evaluation: no results available since no evaluation performed; the lot number associated with this complaint was not reported and remains unknown.No device history record review was able to be performed.Evaluation conclusion: device not returned; known inherent risk of procedure; the investigation was limited to the information reported.The ifu warns that potential adverse events typically associated with surgical mesh materials and their implantation procedures include seroma and infection.In addition, patient factors such as obesity and smoking can directly affect a patient's ability to heal.As per lifecell's key opinion leader, this event pertains to fat necrosis resulting in damaged fat that had liquefied after the removal of the initial drains.It was recommended that the device should not require removal.The lot associated with this complaint was not reported and remains unknown; therefore a review of the device history records could not be performed.Lifecell has made multiple attempts for patient and procedure specific information including the lot number and device disposition, but to date, no additional information has been received.If additional information is received, a follow up report will be submitted.Based on the limited information reported, a relationship between the strattice and this event could not be conclusively determined.No further actions are required, as a nonconformance was not confirmed.

Event Description

It was reported that a patient with a high bmi and a current smoker underwent an abdominal wall repair with strattice (procedure date not reported).Six weeks post operatively, the patient presented with an infected seroma as well as a diagnosis of sirs and septic shock.Drains were reinserted and the patient was placed on antibiotics on (b)(6) 2017.A telephone consultation between lifecell's key opinion leader, dr.(b)(6) and the implanting surgeon, dr.(b)(6) took place on march 29, 2017.Dr.(b)(6) suggested that this event pertains to fat necrosis whereby the undermining necrosis has resulted in damaged fat that has then liquefied after the initial drains were removed.It was recommended that there should not be a need to remove the strattice.

Manufacturer Narrative

No additional investigation was performed.Lifecell's conclusion remains the same.Based on the limited information reported and no associated lot number, a relationship between the strattice and this event could not be conclusively determined.No further actions are required, as a nonconformance was not confirmed.To date, the device remains implanted.As previously reported, the ifu warns that potential adverse events typically associated with surgical mesh materials and their implantation procedures include seroma and infection.In addition, patient factors such as obesity and smoking can directly affect a patient's ability to heal.The device remains implanted.

Event Description

This is a follow up #1 / final to report additional information reported to lifecell by the implanting surgeon on (b)(6) 2017: this is a (b)(6) year old female with a large incisional hernia.The patient underwent an abdominal wall repair with strattice implanted on (b)(6) 2017.Cultures results revealed pseudomonas and streptococcus.The strattice remains implanted and currently the patient has an open wound with draining fluid.She is being treated with a vac dressing.The surgeon did not report what they attribute as to the cause of this event and does not know the associated lot number.

• 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: 6520948
• MDR Text Key: 73667428
• Report Number: 1000306051-2017-00016
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• 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
• Date Manufacturer Received: 05/08/2017
• 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: 42 YR