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Catalog Number E0.8P8
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Erythema (1840); Pain (1994); Swelling (2091); Dizziness (2194); Discomfort (2330); Neck Pain (2433)
Event Date 10/04/2017
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. Mw5073661 ) on 12/19/2017 along with other three incidents ( report no. Mw5073648, mw507649 and mw5073662 ) that occured at this same hospital. After following-up with the hospital, we learned that the culture report was negative for (b)(6). The (b)(6) screening was not done during preop or after the initial surgery on (b)(6) 2017. 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. Patient is known to be diabetic, former smoker and obese. Patients in these category are considered to be at risk for a surgical site infection. 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 lots 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 1220948-2018-00005 for the report no. Mw5073648, mw5073649 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%) with the xenosure patches. 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. Patient returned to the hospital on (b)(6) 2017 with purulent drainage, dizziness and pain at the site of incision. Patient was then readmitted to the hospital on (b)(6) 2017 for wound irrigation and drainage of a superficial abscess of the right neck wound. Two days post-operation, patient still complained of a neck pain, discomfort, swelling, redness, dizziness and pain at the site.
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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 Key7204770
MDR Text Key97732438
Report Number1220948-2018-00004
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 NumberXBU2288
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 Manufactured12/19/2016
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