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

Catalog Number	E0.8P8
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Swelling (2091); Chills (2191)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: XENOSURE BIOLOGICAL PATCH
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7204769
• Report Number: 1220948-2018-00005
• Device Sequence Number: 13824271
• Product Code: FTM
• UDI-Device Identifier: 00840663106295
• UDI-Public: 00840663106295
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K040835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 04/28/2023
• Device Catalogue Number: E0.8P8
• Device Lot Number: XBU2659
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 65