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

Model Number	SG-HBB-31-111-63-12
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/18/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other product used: plug-in leg information: model no.Sg-hbl-56-18, lot no.Cl73772-1, manufacture date.03 jun 2016, expiry date.03 jun 2018.Distal extender information: model no.Sg-hde-18-51, lot no.Cm69179-1, manufacture date.02 dec 2015, expiry date.01 dec 2017.A full review of the device history record 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.The patients' external iliac arteries were 6mm in diameter (right) and 7mm diameter (left), which posed an increased risk for device complications.In the device planning, pre-dilation was identified as being required to allow introduction of the delivery systems.Additionally, patient's vessels were fragile and the clinician advised that the cause of death was not related to the device.The patient had a very stenotic external iliac which was pre-dilated and this caused the iliac vessel to rupture.
Event or Problem Description
Patient died from common iliac artery rupture.Evar was performed on (b)(6) 2016.The physician attempted to introduce the plug-in leg, however came up against resistance, therefore the decision was made to remove the device.The physician ballooned the vessel to aid insertion of the delivery system.The delivery system was re-introduced however, the patient began to hemorrhage.The leg was a planned extension in order to exclude the aneurysm however when implanted it was hoped that it would also create a seal just above the hemorrhage from the upper common iliac artery.Finally, the physician placed a distal extender to complete the procedure.The patient's hemorrhaging continued and the physician was unable to stop the hemorrhaging into the abdomen.The patient passed away during the procedure.

• 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: 5849835
• Report Number: 3004753364-2016-00023
• Device Sequence Number: 18936080
• Product Code: MIH
• UDI-Device Identifier: 05055715611473
• UDI-Public: (01)05055715611473(17)170114(10)CP58756-1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P110032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2016

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: 01/14/2017
• Device Model Number: SG-HBB-31-111-63-12
• Device Lot Number: CP58756-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2016
• Initial Report FDA Received Date: 08/05/2016
• 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: Death
• Patient Age: 84 YR