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

Model Number	SG-HBB-24-81-80-12
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984); Thrombus (2101); Claudication (2550)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other aorfix devices used in the procedure: plug-in leg information: model no.Sg-hbl-90-12, lot no.Cl64290-1, manufacture date.22 june 2015, expiry date.21 june 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.A re-intervention was performed, a fem-fem bypass was carried out.No further issues reported.
Event or Problem Description
Evar was performed on (b)(6) 2016.Date event occurred has been supplied as the 4th week of (b)(6) 2016 (no specific date has been given).Limb occlusion (occurred post procedure) / re-intervention the physician performed the procedure following the ifu and finished it without issues.Sg-hbb was implanted in the abdominal aorta by the right common iliac artery approaching.Sg-hbl-90-14 was placed in the contra-lateral leg.Sg-hbl-90-12 was implanted in the right common iliac artery toward the right external iliac artery.After the procedure, the physician talked with the patient over the telephone and knew that he had claudication.The ct revealed that some thrombotic occlusion existed from the right common iliac artery to the external iliac artery.Re-intervention: in the week of (b)(6) 2016, the patient will visit the hospital and the physician is planning to perform fem-fem bypass for him.Lombard medical representative has advised that a 12mm diameter stent graft was used in an external iliac artery with diameter of 8mm.

• 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: 5633695
• Report Number: 3004753364-2016-00012
• Device Sequence Number: 431398
• Product Code: MIH
• UDI-Device Identifier: 05055715606851
• UDI-Public: (01)05055715606851(17)170604(10)CP62158-1
• 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): 04/29/2016

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: 06/04/2017
• Device Model Number: SG-HBB-24-81-80-12
• Device Lot Number: CP62158-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2016
• Initial Report FDA Received Date: 05/05/2016
• 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: 67 YR