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

Model Number	SG-HBB-24-81-80-20
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/31/2016
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.In this case, the left common iliac artery is approx.18-19 mm in diameter.The instructions for use recommends a 20 mm diameter stent graft in this size of vessel.The endoleak occurred at the landing zone of a correctly sized ipsilateral limb.During planning, a recommendation was made to use a distal extender but this recommendation was not acted upon.The company has not yet had access to image data.It is possible that the selected landing zone was shorter than directed in the ifu, was diseased or irregular.It is also likely that the primary implant was not landed at the intended landing zone and that this was the reason for recommending the use of a distal extender.
Event or Problem Description
The original evar was performed on (b)(6) 2016.An aorfix main body was placed (left side) and an excluder cuff (23mm x 10cm, gore) was deployed as the contralateral leg (right side).The procedure was performed successfully with no endoleaks.Ct images taken on (b)(6) 2016 revealed a type ib endoleak was present at the left common iliac artery on the ipsilateral side.The patient was followed up at this stage in order to monitor the endoleak.After continuous follow up of the patient, it was decided that an additional procedure was required.A re-intervention was performed on (b)(6) 2016 to embolize the left internal iliac artery with coils and an excluder cuff (12mm x 12cm, gore) was placed in the left external iliac artery.The type ib endoleak was resolved.

• 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: 6180792
• Report Number: 3004753364-2016-00033
• Device Sequence Number: 185200
• Product Code: MIH
• UDI-Device Identifier: 05055715606899
• UDI-Public: (01)05055715606899(17)170604(10)CP62228-1
• 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): 12/13/2016

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: 06/04/2017
• Device Model Number: SG-HBB-24-81-80-20
• Device Lot Number: CP62228-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2016
• 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: 63 YR