MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 2540002

Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)

Patient Problems Bacterial Infection (1735); Cellulitis (1768); Erythema (1840); Unspecified Infection (1930); Pain (1994); Hernia (2240)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

Age of patient is estimated at 50 since she was described as being in her early 50s.(b)(4).Lifecell makes multiple attempts to gather additional patient and procedure specific information from the initial reporter, including the lot number and clinical relationship of the device in regards to the event.However, no additional information has been received.Based on the limited information, this patient had a prior diagnoses of infected abdominal space and large hernia defect.As reported, 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.If additional information is reported, a follow up report will be submitted.Our qa investigation was limited to a customer complaint history and resulted in no remarkable findings.

Event Description

It was reported that an obese, female patient in her early 50s, had over 40 abdominal operations.Prior to strattice placement, the patient came in with a chronic exposed infected mesh requiring repair of a hernia defect that was over 25 cm by 25 cm.Strattice was placed in the infected space.Three weeks later, the patient experienced redness and pain.The surgeon removed the strattice and was not able to use any other scaffold / adm in this situation due to poor quality and thinness of the abdominal wall fascia.

Manufacturer Narrative

Age of patient is estimated at 50 since she was described as being in her early 50s.(b)(6), due to serious injury the event was reported to the fda in an abundance of caution.On follow up, the surgeon explained that the event was due to the sick patient with likely immunodeficiency and multiple prior abdominal wall infections with resistant bacteria and a very large complex hernia.The event is unrelated to strattice.Based on our internal review of the device processing history, the lot met qc criteria for product release.The lot was aseptically processed and terminally sterilized within process parameters.No deviations or nonconformance had been encountered in association with the event.No other complaints involving serious injury were reported against lot sp100349.

Event Description

As reported by the implanting surgeon on follow up: the dates of implant and removal of the strattice mesh are (b)(6) 2016 and (b)(6) 2016, respectively.Primary closure was initially achieved on (b)(6) 2016 with component separation and strattice underlay.Patient re-presented to er (b)(6) 2016 with abdominal surgical site infection and cellulitis.The patient was then taken to the or for strattice removal and wound vac placement as fascial closure was not possible due to size of the defect, intraabdominal adhesions, and friability of the fascia.The reason for removing the strattice was due to the patient being grossly infected with frank purulence coating the mesh.The cause of the event is attributed to the sick patient with likely immunodeficiency and multiple prior abdominal wall infections with resistant bacteria and a very large complex hernia.Currently, the patient has healed skin flaps over bowel and large hernia underneath with no infection.

• 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: 7072590
• MDR Text Key: 93429595
• Report Number: 1000306051-2017-00091
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: 2540002
• Device Catalogue Number: N/A
• Device Lot Number: SP100349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• 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: 50 YR