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 Codes	Aneurysm (1708); Occlusion (1984)
Date of Event	12/21/2016
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 an attempt was made to push up the delivery system in order to deploy the main body against the greater curvature of the proximal neck whilst deploying the contralateral socket.The left lower renal artery remains occluded.The patient's creatinine level post-procedure increased by 2.0 mg/dl.It has not been possible to confirm creatinine levels pre-procedure.Currently, there is no report of the patient being symptomatic as a result of the left renal artery occlusion and the patient has been discharged from the hospital.There is no plan for re-intervention at this time and it has been confirmed by the physician that dialysis is not required.The patient will continue to be monitored.Follow-up ct scans have been requested however it has not been possible for the sales representative to obtain these from the hospital.Device remains implanted in patient.
Event or Problem Description
Original evar was performed on (b)(6) 2016.After deploying the contralateral gate, the support tube was released.The contralateral leg was cannulated and the proximal portion was touched-up.The ipsilateral limb of the main body was deployed.An excluder cuff (27 mm) was added to the contralateral side and another excluder cuff (12 mm) added to the ipsilateral side.On completion of the procedure, the final angiography revealed a complete occlusion of the left lower renal artery.The physician attempted to locate the left renal artery with a guidewire of 0.035 mm from the brachial artery approach but this was not possible.The physician completed the procedure with the left renal artery remaining occluded.

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD.; 4 trident park; didcot, oxfordshire OX11 7HJ; UK OX11 7HJ
• MDR Report Key: 6275550
• Report Number: 3004753364-2017-00003
• Device Sequence Number: 13822267
• Product Code: MIH
• UDI-Device Identifier: 05055715606509
• UDI-Public: (01)05055715606509(17)180920(10)CP76866-1
• 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): 01/23/2017

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: 09/20/2018
• Device Model Number: SG-HBB-24-111-80-14
• Device Lot Number: CP76866-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2016
• Initial Report FDA Received Date: 01/25/2017
• 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: Disability
• Patient Age: 87 YR