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

Model Number	SG-HBB-31-81-63-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984); Renal Failure (2041); Vascular Dissection (3160)
Date of Event	06/02/2016
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.The physician stated that the proximal neck was short and not in good condition.
Event or Problem Description
Original evar was performed on (b)(6) 2016.The procedure was performed by placing a main body from the right approach following the ifu.The physician placed and deployed a main body (hbb-31-81), so that the fishmouth trough would be positioned approximately 2 mm distally from the left lower renal artery.Thereafter, he released a support tube, deployed an ipsi-lateral limb, removed the delivery system from the patient's body, and inflated a balloon catheter for the touch-up.It was seemed to the physician that the fishmouth trough was positioned about 5 mm distally from the left lower ra as a result.Then, he placed a contra-lateral limb (hbl-56-20) and an ipsi-lateral limb (hde-20-51).An angiography revealed a definitive type ia endoleak.By inflating the balloon catheter additionally, the type ia endoleak was decreased.Therefore, the physician observed the inside of the main body with an angiography.No endoleaks were confirmed.Thus, he concluded that it was not a type iv endoleak.Thereafter, he placed an extender (hpe-31-38) right below the ra.The procedure was finished after completely resolving the endoleak.A follow up ct performed on (b)(6) revealed that the left lower renal artery was completely occluded.On (b)(6), an angiography and ptra were performed.The angiography confirmed the complete occlusion of the left lower renal artery.The physician searched the left renal artery with a guide wire and catheter approaching from the left brachial artery, but it could not be detected.Additionally, the creatinine level has increased from 1.7 (pre-operative) to 2.4.When taking an angiography by using a catheter, the physician confirmed a dissection-like pool of contrast agents.

• 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: 5747548
• Report Number: 3004753364-2016-00019
• Device Sequence Number: 443
• Product Code: MIH
• UDI-Device Identifier: 05055715611879
• UDI-Public: (01)05055715611879(17)170108(10)CP58612-1
• 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): 06/20/2016

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: Health Professional
• Device Expiration Date: 08/01/2017
• Device Model Number: SG-HBB-31-81-63-20
• Device Lot Number: CP58612-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2016
• Initial Report FDA Received Date: 06/24/2016
• 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: 73 YR