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

Model Number	SG-HBB-31-81-80-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802)
Date of Event	06/22/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other product used: plug-in leg information: model no.Sg-hbl-56-12, lot no.Cl60954-1, manufacture date.17 march 2015, expiry date.16 march 2017.Proximal extender information: model no.Sg-hpe-31-38, lot no.Cq59955-1, manufacture date.18 february 2015, expiry date.17 february 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.From a review of the patient's anatomy, the proximal neck is highly angulated.The physician has stated that due to the first time use of the product, it was difficult to land the proximal extender as it is short in length.Review of the patient scans identified anatomical issues and concerns regarding device selection.
Event or Problem Description
Original evar was performed on (b)(6) 2016.After placing the main body and a contra-lateral limb, the physician inflated a balloon catheter.The final angiography revealed a type 1a endoleak in the proximal portion.The physician re-ballooned, however, the endoleak was not resolved.The physician placed a proximal extender (sg-hpe), however the endoleak still remained.Finally, an endurant cuff (medtronic) was implanted.On final run, the type 1a and type 4 remained.The procedure was finished and the patient was to be followed-up.Update received on 22 jun 2016, the aneurysm had ruptured and the patient died.

• 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: 5789084
• Report Number: 3004753364-2016-00021
• Device Sequence Number: 1195950
• Product Code: MIH
• UDI-Device Identifier: 05055715611893
• UDI-Public: (01)05055715611893(17)170210(10)CP59770-1
• 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): 07/12/2016

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: 02/10/2017
• Device Model Number: SG-HBB-31-81-80-12
• Device Lot Number: CP59770-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2016
• Initial Report FDA Received Date: 07/13/2016
• 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: 75 YR