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

Model Number	SG-HBB-34-96-80-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The index procedure was performed on (b)(6) 2017.The neck angle was 90 degrees and an sma to distal renal distance of 3-5mm.The implant was landed low to avoid impingement of the sma by the anterior peak of the fishmouth.A type 1a endoleak was identified likely originating at the trough of the fishmouth because of the low placement of the device.At re-intervention on (b)(6), an aorfix cuff was placed rotated 90 degrees to the primary graft in order to cover the origin of the leak.This was not completely successful and a competitor cuff was also placed.A minor type 1a endoleak still remained and the patient was returned to the ward.It has been confirmed that there is no enlargement of the aneurysm.The patient will be followed up 4-6 weeks after the re-intervention.
Event or Problem Description
Original evar performed (b)(6) 2017.Identified a type 1a endoleak during patient follow-up on (b)(6) 2017.Re-intervention planned and performed on (b)(6) 2017.

• 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: 6893077
• Report Number: 3004753364-2017-00008
• Device Sequence Number: 10967608
• Product Code: MIH
• UDI-Device Identifier: 05055715637442
• UDI-Public: (01)05055715637442(17)170823(10)CR63895-1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P110032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: 08/23/2017
• Device Model Number: SG-HBB-34-96-80-12
• Device Lot Number: CR63895-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/26/2017
• 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: 77 YR