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Catalog Number E0.8P8
Device Problem Insufficient Information (3190)
Patient Problems Fever (1858); Unspecified Infection (1930); Swelling (2091); Chills (2191)
Event Date 11/13/2017
Event Type  Injury  
Manufacturer Narrative
We have not received the patch for evaluation since the patch remains implanted in the patient. Hence, we could not conclusively determine the root cause of the defect. We were notified about this incident through fda ( report no. Mw5073662 ) on (b)(6) 2017 along with other three incidents ( report no. Mw5073648, mw5073649 and mw5073661 ) that occured at this same hospital. After following-up with the hospital, we learned that the culture report was positive for streptococcus agalactiae growth. Ct angiogram performed on (b)(6) 2017 revealed soft tissue abnormality at the site of the prior right cea compatible with abscess formation. Streptococcus agalactiae 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. Streptococcus agalactiae infection is almost always associated with underlying abnormalities. In elderly persons, streptococcus agalactiae infection is strongly linked with congestive heart failure and being bedridden (b)(4). Facility conducted an extensive analysis of this series. They concluded that the infections were not related to the patch. However, the exact root cause was not determined. 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. Please note that we have also submitted manufacturer report numbers: 1220948-2018-00002, 1220948-2018-00003 and 1220948-2018-00004 for the report no. Mw5073648, mw5074649 and mw5073661, respectively for the other three cases of the infection that occured at the same hospital. Infections can occur in any wound recognizing however that this is a very infrequent occurence for carotid artery surgery. The rate of occurrence for these kinds of incidents has remained very low ((b)(4)). The fact that the organisms differ in each of the specimens in each cases also indicates that the infection was from an external source or carrier. While the root cause(s) of this incident remains inconclusive, we do believe that it is highly unlikely that the xenosure patch contributed to the incident.
Event Description
Patient underwent a right carotid endarterectomy with patch angioplasty on (b)(6) 2017. Deep incisional ssi was detected with fever chills and increased swelling of right side of the neck. Patient was re-admitted to the hospital on (b)(6) 2017 for incision and drainage.
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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 Key7204769
MDR Text Key97721858
Report Number1220948-2018-00005
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberE0.8P8
Device Lot NumberXBU2659
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 Received12/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2017
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: 01/18/2018 Patient Sequence Number: 1