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

Model Number	SG-HBB-24-81-63-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984)
Date of Event	06/03/2016
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 devices have not met the final release criteria.It has been reported that the patient had a 115° proximal neck angle which falls outside of the devices indications for use.Currently, there is no report of the patient being symptomatic due to the loss of right renal artery function and there is no plan for re-intervention.
Event or Problem Description
The procedure was performed by placing a main body device from the right approach following the ifu.Because the right common iliac artery had an aneurysm, the physician preoperatively planned to place an excluder device (gore, dia.: 23 mm) in the distal portion of the ipsilateral side.The physician went on to deploy a contra-lateral limb however due to a technical error, the overlapping margin was insufficient.The physician added an extender (hde-12-82) as a bridge to address this issue.Following review of the distal landing zone, further extension was required and the physician extended it with a distal extender device.Additionally, he also placed a bare stent to prevent stenosis while performing a landing in the external iliac artery.The final angiography revealed a type iv endoleak and an occlusion of the right lower renal artery.As a countermeasure, the physician attempted to approach from the brachial artery, but cannulation in the renal artery was unsuccessful therefore not progressed.The physician placed an additional bare stent in order to obtain a good blood flow to the left renal artery.The procedure was finished.

• 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: 5741606
• Report Number: 3004753364-2016-00020
• Device Sequence Number: 10808356
• Product Code: MIH
• UDI-Device Identifier: 05055715606813
• UDI-Public: (01)05055715606813(17)170517(10)CP61964-1
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2016

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: Health Professional
• Device Expiration Date: 05/17/2017
• Device Model Number: SG-HBB-24-81-63-16
• Device Lot Number: CP61964-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2016
• Initial Report FDA Received Date: 06/22/2016
• 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: 82 YR