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

Model Number	SG-HBB-31-81-80-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Atherosclerosis (1728); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	11/15/2015
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 devices have not met the final release criteria.Patient's physiology: proximal neck curve: 90°proximal neck length: 40 mm.Ipsilateral access vessel diameter: 8 mm.(left).Contralateral access vessel diameter: 7.5 mm.(right).Calcification present at point of damage.Due to arteriosclerosis making repair difficult, a vascular prosthesis was placed to repair the damaged vessel.
Event or Problem Description
Event: left common femoral artery damaged by main body delivery system.The procedure was initiated by inserting a main body from the left common femoral artery approach, then the physician placed a contralateral limb (hbl) from the right approach and distal extender from the left approach.The physician experienced difficulty in inserting the main body delivery system by approaching from the left common femoral artery.Eventually, all the planned devices were placed successfully and no endoleaks were confirmed.Final angiography revealed damage to the left common femoral artery.A piece of vascular prosthesis (approximately 3 cm in length) was inserted to repair the damage and 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: 5969385
• Report Number: 3004753364-2016-00028
• Device Sequence Number: 391538
• Product Code: MIH
• UDI-Device Identifier: 05055715611909
• UDI-Public: (01)05055715611909(17)170121(10)CP59072-1
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2016

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: 01/21/2017
• Device Model Number: SG-HBB-31-81-80-14
• Device Lot Number: CP59072-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2016
• Initial Report FDA Received Date: 09/22/2016
• 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: Other