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

Model Number	SG-HBB-31-96-80-12
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/22/2016
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.On (b)(6) 2016, although the overall angiography did not show any particular endoleak, a re-intervention was performed as a precautionary measure to prevent a type 1a endoleak, by placing an excluder proximal cuff (32 mm, gore).The physician has stated that the device was placed lower than expected therefore the main body (31mm in diameter) was placed at the area of the proximal neck which had a diameter of 22 - 23 mm.From a review of the patient's anatomy, the proximal neck angle is 64° and is aneurysmal with some calcification present.This may have been a contributing factor to the type 1a endoleak.
Event or Problem Description
The original evar was performed on (b)(6) 2016.The final angiography revealed a type iv endoleak.Then, the procedure was finished.On (b)(6), 6 days after the procedure, the ct image revealed a suspected type ia endoleak.The follow up angiography did not identify any particular endoleak.On (b)(6), a re-intervention was performed and an excluder proximal cuff (32 mm, gore) was added as a precautionary measure to prevent a possible type 1a endoleak occuring in the future.

• 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: 6180322
• Report Number: 3004753364-2016-00032
• Device Sequence Number: 575855
• Product Code: MIH
• UDI-Device Identifier: 05055715612074
• UDI-Public: (01)05055715612074(17)180406(10)CP71831-1
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2016

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: Physician
• Device Expiration Date: 04/06/2018
• Device Model Number: SG-HBB-31-96-80-12
• Device Lot Number: CP71831-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/16/2016
• 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: 89 YR