MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. XENOSURE BIOLOGICAL PATCH; MESH, SURGICAL

Catalog Number 1BV10

Device Problem Microbial Contamination of Device (2303)

Patient Problem Aneurysm (1708)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

We have not received the patch for evaluation since the patch has been discarded by the hospital.We have confirmed the reported incident from the images of the ct scan that was provided to us by the hospital.Although the investigation is ongoing, our initial investigation has determined that the xenosure device is not likely a contributor to these issues - particularly when considering the patch's continued use by this institution in other vascular beds, without any similar complications.We further have analyzed our complaint records for similar series or incidents and have found only one other report of anuerysm with infection in a single patient from 2012 which indicates no trends.Including this report, our reported rate of incidence is (b)(4) in (b)(4) units sold.((b)(4)).Streptococcus schleiferi is known to be highly susceptible to destruction from our 0.2% glutaraldehyde storage solution.Further, our studies have shown that the hardest to sterilize/remove bacteria for our process are the bacillus and clostridium strain for which we have conducted extensive validation work to prove effectiveness of the sterilization process.Our review of the sterilization information for this lot found no abnormalities that would suggest a failure of the process.These facts indicate that these strains could not survive through our sterilization process or storage in the storage solution and indicates that the source of infection is some other cause.Staphylococcus schleiferi is a coagulase-negative subspecies that occasionally causes skin and ear infections in dogs and can also be found in healthy animals.( source: https://www.Wormsandgermsblog.Com/2010/07/articles/animals/dogs/is-staphylococcus-schleiferi-zoonotic/ ).The patient has a dog in his home.However, we cannot confirm if he was sick.Although the risk of transfer from the animal to human is low, it remains a possibility that the infection was transmitted from the animal since healthy dogs and cats also carry this bacterium.Moreover, the infection occurred almost a year after the implantation of the patch which strongly suggest that the source of infection is something else rather than the patch itself.The review of lot history records did not reveal any discrepancies related to the complaint events either during the manufacturing or packaging processes for this lot and had passed all required tests.We have also not received any other complaints from other customers for devices from this lot.

Event Description

Patient underwent a carotid artery revascularization with patch angioplasty on (b)(6) 2017.No issue was noted during the index surgery.During follow-up on (b)(6) 2018, aneurysmatic dilatation on left carotid artery at the site of the patch was discovered.Patch was then removed and replaced with a new patch.Culture performed on the explanted patch identified staphylococcus scheiferi.Patient is currently being treated with intravenous antibiotics.

• Brand Name: XENOSURE BIOLOGICAL PATCH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 7508006
• MDR Text Key: 108051031
• Report Number: 1220948-2018-00030
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K040835
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 1BV10
• Device Lot Number: XBU2194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2018
• 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): Hospitalization; Required Intervention