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

Model Number	SG-HBB-31-96-80-14
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802)
Date of Event	04/24/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other aorfix product used in the procedure: plug-in leg information: model no.Sg-hbl-90-14, lot no.Cl67199-1, manufacture date.24 sep 2015, expiry date.23 sep 2017.Proximal extender information: model no.Sg-hpe-31-38, lot no.Cq62357-1, manufacture date.14 may 2015, expiry date.13 may 2017.Distal extender information: model no.Sg-hde-14-51, lot no.Cl67199-1, manufacture date.20 mar 2015, expiry date.19 mar 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.It has been reported that the patient had a 100° proximal neck angle.From a review of the sizing sheet, the patient had access vessels of 7.5mm and 7.9mm and from a review of the schema, the patient had an excessively tortuous left common iliac (angle between the abdominal aorta and the common iliac artery measured 130 degrees).The patient's anatomy (neck angle and access vessel diameter) falls outside of lombard medical's indications and recommendations for use and therefore this case was performed off label.The patient passed away in hospital at (b)(6) years of age.
Event or Problem Description
Original evar was performed (b)(6) 2016.Reported to lombard medical on 27 apr 2016 (no report of death).Following the ifu, a main body (hbb-31-96-80) was inserted from the left approach and a contra-lateral limb (hbl-90-14) was placed.Type ia endoleak was confirmed.Although it was attempted to add a distal extender (hde-14-51) in the ipsi-lateral limb, it was impossible to push up the device due to the excessively tortuous common iliac artery.In order to address the situation 2), the physician attempted to add a proximal extender from the contra-lateral side over the egoist guide wire ((b)(4)) by inflating a balloon catheter around the proximal neck.However, the device would not advance and it was switched to advance it from the ipsi-lateral side.Although those attempts were made, the device would not advance in the end.Finally, the physician placed a cuff (gore, 32 mm) instead.As a result, the type ia endoleak was resolved.The physician finished the procedure, even though the final angiography revealed a type iv endoleak.In order to watch it, the patient will be followed-up from now on.Patient passed away on (b)(6) 2016.This was reported to lombard medical on 10 may 2016.

• 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: 5690605
• Report Number: 3004753364-2016-00016
• Device Sequence Number: 31838
• Product Code: MIH
• UDI-Device Identifier: 05055715612081
• UDI-Public: (01)05055715612081(17)170612(10)CP63917-1
• 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): 05/27/2016

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: 06/12/2016
• Device Model Number: SG-HBB-31-96-80-14
• Device Lot Number: CP63917-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2016
• Initial Report FDA Received Date: 06/01/2016
• 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