MAUDE Adverse Event Report: LOMBARD MEDICAL LTD. AORFIX AAA FLEXIBLE STENT GRAFT; ENDOVASCULAR STENT GRAFT

Model Number	SG-HBB-24-111-80-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full review of the device history record for this device has been carried out with no anomalies identified; product was manufactured and released for sale in accordance with specifications.There is no information to suggest that the device has not met the final release criteria.The physician has stated that it is possible that the endoleak/migration may have been present but was not identified at the end of the initial procedure performed on (b)(6) 2016.Scans have been requested to confirm the cause of the endoleak but this information has not yet been received.Device remains implanted in patient.
Event or Problem Description
Original evar was performed on (b)(6) 2016.The procedure was completed successfully with no issues.During the 3 month follow-up ((b)(6) 2017), an angiography revealed a type 1a endoleak.A re-intervention was scheduled and performed on (b)(6) 2017 performing a coil embolization (approximately 50 pieces of coils) to resolve the endoleak.The re-intervention was successful.

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD.; 4 trident park; didcot, OX11 7HJ; UK OX11 7HJ
• MDR Report Key: 6386797
• Report Number: 3004753364-2017-00004
• Device Sequence Number: 10946764
• Product Code: MIH
• UDI-Device Identifier: 05055715609227
• UDI-Public: (01)05055715609227(17)171104(10)CP68399-1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2017

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: 11/04/2017
• Device Model Number: SG-HBB-24-111-80-14
• Device Lot Number: CP68399-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/08/2017
• 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: 87 YR