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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.
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Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
63 second ave
burlington MA 01803
Manufacturer (Section G)
63 second ave
burlington MA 01803
Manufacturer Contact
pragya thikey
63 second ave
burlington, MA 01803
MDR Report Key7508006
MDR Text Key108051031
Report Number1220948-2018-00030
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1BV10
Device Lot NumberXBU2194
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/13/2018
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 Treatment Data
Date Received: 05/11/2018 Patient Sequence Number: 1