MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE SURGICAL MESH

Model Number UNKNOWN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Inflammation (1932); Necrosis (1971); Ulceration (2116)

Event Type  Injury  

Manufacturer Narrative

Method: actual device not evaluated; it was confirmed that this event was not reported to lifecell as a complaint against strattice. The available information is limited to the published case study. No manufacturing review could be performed without a device lot number. Results: no results available since no evaluation performed. Conclusion: device not returned; known inherent risk of procedure. Strattice is an acellular xenograft derived from porcine tissue that could elicit an immune response in patients with known sensitivity. The instructions for use notifies the customer that the porcine tissue grafts are contraindicated and should not be used in patients with a known sensitivity to porcine material or polysorbate 20, a component of the phosphate buffered aqueous solution. Based on the patch testing performed on this patient, it was confirmed that this patient had a hypersensitivity to the strattice. The patient's death was reported to be from an unrelated cause. The available information is limited to the published case study. Dates associated with surgeries, treatments and the patient's death were not reported. Multiple physicians are listed as authors of this case study but the physician(s) and hospital(s) that treated this patient remains unknown. Due to the limited information available, no internal investigation into the strattice lot could be performed. Additional information was requested from case study author, dr. D. Kroshinsky. Although a response was received, no additional information has been provided to date. If additional information is received, this complaint will be reopened for investigation and a follow up report will be filed.

Event Description

Through a literature review, lifecell identified a serious adverse event in a published case study titled 'delayed type iv hypersensitivity reaction to porcine acellular dermal matrix masquerading as infection resulting in multiple debridements'. It was confirmed that this event was not reported to lifecell as a complaint against strattice. As reported in the case study, the (b)(6) male patient presented with a non-healing abdominal wound of 1 year duration. The patient had a history of nissen fundoplication 3 years prior to presentation that was complicated by a ventral hernia, infected polytetrafluoroethylene mesh [dualmeshtm], small bowel obstruction, and recurrent superficial wound infections. Prior treatment attempts included multiple antibiotic regimens, hyperbaric oxygen, and mesh replacement, the most recent of which was the implantation of strattice, placed 6 months prior to presentation. Dates of prior surgeries, treatments and the implantation of strattice were not reported in the case study. Following the placement of the strattice, the patient underwent 17 returns to the operating room for debridement, including two attempts at skin grafting. Despite serial debridements to healthy, bleeding tissue, the wound necrosis persistently recurred. Per outside hospital records, all pathological analyses of debridement specimens demonstrated non-specific inflammatory pathology. Cultures of the specimens were sterile or demonstrated antibiotic-sensitive skin flora or yeast. Hyperbaric oxygen therapy and multiple antibiotic regimens had been trialed at the outside hospital, the most recent of which was a combination of voriconazole, ertapenem, and linezolid. No improvement was noted. Upon presentation, a broad differential diagnosis was considered including wound super infection, vasculitis, pyoderma gangrenosum, and hypersensitivity reaction. Patch testing at 48 and 72 hrs indicated a reaction to the biologic mesh material (strattice), with full thickness ulceration and vesicular dermatitis noted at the testing site. The strattice was scheduled for surgical removal at the outside hospital. Unfortunately, the patient expired after the mesh was replaced from an unrelated cause. The date of strattice explantation and patient's death were not reported in this case study.

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: stanley dube ; one millennium way; branchburg, NJ 08876 ; 9089471575
• MDR Report Key: 5379751
• MDR Text Key: 36396186
• Report Number: 1000306051-2016-00005
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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?

• Event Location: No Information
• Date Manufacturer Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/20/2016 Patient Sequence Number: 1