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

Model Number	SG-HBB-24-96-80-18
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/03/2016
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 device has not met the final release criteria.A re-intervention was performed on (b)(6) 2016 to treat the presence of a type 2 endoleak due to aneurysm enlargement of 1cm.At this point, a type 3b endoleak was identified by the clinician from a needle hole of the main body where the stent graft wasn't fully expanded.The physician considered adding an aortic cuff into the implanted aorfix, however, as an open repair had already been initiated, the aorfix stent graft was explanted and was replaced with a y-graft to resolve the type 3b endoleak.As per the instructions for use, the physician could have ballooned the aorfix stent graft to resolve the endoleak, however, as they were already performing an open repair to resolve the type 2 endoleak, it was decided to explant aorfix and replace with a y graft.In this case, it is possible that the size of the main body used (24mm diameter) was excessively oversized for the size of the aorta as the clinician reports that the main body did not expand sufficiently.Therefore if the graft is unable to fully expand, this can lead to the wire rungs of the graft forming 'elbows' and can result in tension on the sutures leading to suture hole enlargement and leakage through the suture hole (type 3b endoleak).The patient has been discharged from hospital and is doing well.
Event or Problem Description
Original evar was performed on (b)(6) 2015.A small type 4 endoleak remained at the end of the procedure.A re-intervention was performed on (b)(6) 2016 to treat the presence of a type 2 endoleak due to aneurysm enlargement of 1cm.At this point, a type 3b endoleak was identified by the clinician from a needle hole of the main body where the stent graft wasn't fully expanded.The physician considered adding an aortic cuff into the implanted aorfix, however, as an open repair had already been initiated, the aorfix stent graft was explanted and was replaced with a y-graft to resolve the type 3b endoleak.

• 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: 6059975
• Report Number: 3004753364-2016-00030
• Device Sequence Number: 13575042
• Product Code: MIH
• UDI-Device Identifier: 05055715607063
• UDI-Public: (01)05055715607063(17)020215(10)CP59044-1
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2016

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: 02/01/2017
• Device Model Number: SG-HBB-24-96-80-18
• Device Lot Number: CP59044-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2016
• Initial Report FDA Received Date: 10/27/2016
• 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: 88 YR