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

Model Number	SG-HBB-24-96-80-12
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full review of the device history records for these devices 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.From a review of the patient's anatomy, the terminal aorta reduced in diameter distally from 17mm to 15mm over a length of 22mm.The ifu explicitly warns "placement of the implant in an aorta with a diameter of 18mm or less in the region of the gate can result in occlusion of the ipsilateral limb".The anatomy in this case carried a clear warning of the risk of ipsilateral limb occlusion.
Event or Problem Description
Original evar was performed (b)(6) 2016.The physician successfully completed the procedure with no issues.When the patient was followed up on (b)(6) 2016, the angiography revealed that an occlusion was present in the ipsilateral limb.The physician decided to perform a re-intervention that day by proceeding with a fem-fem bypass.

• 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: 6180804
• Report Number: 3004753364-2016-00034
• Device Sequence Number: 938915
• Product Code: MIH
• UDI-Device Identifier: 05055715607032
• UDI-Public: (01)05055715607032(17)180602(10)CP73647-1
• 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): 12/13/2016

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: Physician
• Device Expiration Date: 06/02/2018
• Device Model Number: SG-HBB-24-96-80-12
• Device Lot Number: CP73647-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 12/16/2016
• 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: Required Intervention
• Patient Age: 75 YR