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Catalog Number E0.8P8
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Post Operative Wound Infection (2446)
Event Date 10/15/2017
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. Mw5073649)on 12/19/2017 along with other three incidents ( report no. Mw5073648, mw5073661 and mw5073662) that occured at this same hospital. After following-up with the hospital, we learned that the culture report was (b)(6) growth. Significant purulent discharge was observed during the time of incision and drainage in the or. (b)(6) 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. People can carry (b)(6) in their nose and on their skin without any symptoms. It is possible that the patient got infected with (b)(6) when the surgical wounds were in contact with someone or some surgical instruments during the surgery with exposed (b)(6). Patient is known to be diabetic, smoker and obese. The patients in these category is considered to be at risk for a surgical site infection. Facility conducted an extensive analysis on this series. They concluded that the infection was 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, 1220948-2018-00004 and 1220948-2018-00005 for the report no. Mw5073648, mw5073661 and mw5073662, 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 (0. 001%). 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 had a left carotid endarterectomy with patch angioplasty on (b)(6) 2017. Patient returned to the hospital on (b)(6) 2017 with swelling, redness and pain over the left neck. Infection had extended deep into the carotid sheath area. Deep incisional surgical site infection was observed.
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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 Key7204768
MDR Text Key97712560
Report Number1220948-2018-00003
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 01/17/2018
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 NumberXBU2460
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 Manufactured02/15/2017
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