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

Model Number	SG-HBB-24-96-80-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984); Claudication (2550)
Date of Event	12/28/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Plug in leg information: model no.Sg-hbl-90-20, lot no.Cl62469-1, manufacture date.13 may 2015, expiry date.12 may 2015.Model no.Sg-hbl-56-20, lot no.Cl62021-1, manufacture date.21 apr 2015, expiry date.20 apr 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.
Event or Problem Description
Evar performed on (b)(6) 2015.Follow up ct on (b)(6) 2015 revealed occlusion of right and left internal iliac arteries, however no action was taken at this time.On (b)(6) 2016, the patient visited the hospital complaining of claudication in their left leg.Abi was measured at 0.56.Re-intervention was performed on (b)(6) 2016 to implant a stent in the left internal iliac artery to restore flow.At the end of the procedure, the physician could confirm that there was no pressure difference between the brachial part and the leg part displayed on the monitor after the placement of the stent.The physician believed that the blood flow should be improved and the claudication of the left leg will disappear.The right internal iliac was not addressed as the patient was experiencing symptoms in the left leg only, therefore the right internal iliac remains occluded.The patient will be followed up at a later date.The physician states that it was very hard to determine the landing position of the distal fishmouth.The patient did not have any history of pad prior to the procedure.

• 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: 5446651
• Report Number: 3004753364-2016-00007
• Device Sequence Number: 16325278
• Product Code: MIH
• UDI-Device Identifier: 05055715607032
• UDI-Public: (01)05055715607032(17)170517(10)CP61429-1
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2016

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: 05/17/2017
• Device Model Number: SG-HBB-24-96-80-12
• Device Lot Number: CP61429-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2016
• Initial Report FDA Received Date: 02/19/2016
• 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; Disability
• Patient Age: 66 YR