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

Model Number	SG-HBB-24-111-80-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984)
Date of Event	08/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Plug-in leg information: model no.Sg-hbl-56-18, lot no.Cl66934-1, manufacture date.To be entered, expiry date.17 september 2017.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.From a review of the patient's anatomy, the proximal neck was highly angulated (95 degrees) therefore this case was performed outside the indications for use.The left internal iliac remains occluded and the left lower renal artery remains partially occluded.A type 4 endoleak was also present.The patient will be followed up as per routine procedure.There is no report of the patient being symptomatic and there is no plan for re-intervention.
Event or Problem Description
Event - partial occlusion of renal artery.The physician performed an evar procedure to treat an aaa following the ifu.The main body was inserted by the right approach.During deployment, the proximal neck of the main body appeared to take an accordion shape.Thereafter, the physician placed the main body right below the left lower renal artery by adjusting the fishmouth troughs.The final angiography revealed that the left lower renal artery was covered by half and a type 1a endoleak was present.The internal iliac artery had also been occluded.While attempting to cannulate the left renal artery, lunderquist guide wire (cook japan, 260 cm) only passed through it, but the cx angiography catheter (gadelius, 4 fr) would not advance due to an entrapment by the proximal fishmouth trough of the main body.The physician gave up the placement of the stent at the renal artery.From a review of the patient's anatomy, the proximal neck was highly angulated (95 degrees) therefore, this case was performed outside of the device indications for use.

• 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: 5965959
• Report Number: 3004753364-2016-00026
• Device Sequence Number: 510344
• Product Code: MIH
• UDI-Device Identifier: 05055715606516
• UDI-Public: (01)05055715606516(17)180531(10)CP73468-1
• 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): 09/19/2016

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: 05/31/2018
• Device Model Number: SG-HBB-24-111-80-16
• Device Lot Number: CP73468-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2016
• Initial Report FDA Received Date: 09/21/2016
• 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: Hospitalization
• Patient Age: 81 YR