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

Model Number	SG-HBB-24-111-63-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Requests have been made to obtain additional information such as scans/anatomical information and relevant clinical information which have not been forthcoming.If information becomes available at a later date, an assessment will be made and a follow-up report will be submitted.
Event or Problem Description
Event: re-intervention for type 2 endoleak, 1b endoleak (left) and type 3b endoleak (distal, posterior aspect of the bifurcated segment).Original evar: (b)(6) 2016.Type 2 endoleak identified on post-op scan.One month post-evar: (b)(6) 2016.Cta scan shows sac size at 47 x 45mm.Between 6 and 14 months post-evar: (b)(6) 2016 to (b)(6) 2017.Cta scans show sac size to be significantly enlarged at 57 x 54mm.Re-intervention: (b)(6) 2017.To treat original type 2 endoleak, but procedure commenced with the view that the patient may also have a type 1b endoleak at the distal end of the right limb of the stent graft.During re-intervention: type 1b endoleak was confirmed from the left limb of the stent graft, and a type 3b endoleak was also identified coming from the distal, posterior aspect of the bifurcated segment of the stent graft.The stent graft was completely relined using a combination of competitor devices.Post-deployment scan: all endoleaks resolved.One month post-op: (b)(6) 2017.Follow-up scan showed no evidence of endoleak.However, delayed images showed faint, diffuse type 2 lumbar endoleak.Manufacturer awareness of the event was via device tracking system.

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD.; 4 trident park; didcot, OX11 7HJ; UK OX11 7HJ
• MDR Report Key: 7111919
• Report Number: 3004753364-2017-00009
• Device Sequence Number: 1156756
• Product Code: MIH
• UDI-Device Identifier: 05055715606431
• UDI-Public: (01)05055715606431(17)161203(10)CP57479-1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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: 12/03/2016
• Device Model Number: SG-HBB-24-111-63-12
• Device Lot Number: CP57479-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/13/2017
• 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: 86 YR