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

Model Number	SG-HBB-31-111-80-12
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); Infarction, Cerebral (1771); High Blood Pressure/ Hypertension (1908); Occlusion (1984); Peripheral Vascular Disease (2002); Thrombus (2101)
Date of Event	07/29/2016
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.A re-intervention was performed to treat the peripheral vascular thrombotic occlusion by placement of a zilver stent (cook) which was successful.The endoleak was also resolved by placing an excluder 32mm cuff.The patient was administered heparin to address the post-op cerebral infarction.It was confirmed that plaque was present at the brachiocephalic artery and the infarction was more serious at the right portion.The physician believes that a possible cause of the infarction might be due to the manipulation of the catheter from the brachial artery, and additional information received on 09 aug 2016 states that it is possible that the thrombosis travelled to the cerebral vessels while manipulating the competitor's catheters around the aortic arch by reaching access from both sides of the brachial arteries combined with the length of the procedure time.
Event or Problem Description
Evar was performed on (b)(6) 2016.Cerebral infarction and peripheral thrombotic occlusion on both sides.Re-intervention performed to treat thrombotic occlusion and endoleak also resolved.The procedure was performed by placing a main body from the right approach following the ifu.Final angiography revealed a type 1a endoleak at the proximal neck.The decision was made to monitor the endoleak.Post operation, after admission to icu, the patient experienced a cold sensation in both lower legs.The physician confirmed a suspected peripheral vascular thrombotic occlusion which was present.At this point, it was also confirmed that there were symptoms of cerebral infarction.A re-intervention was performed to treat the peripheral vascular thrombotic occlusion by placement of a zilver stent (cook) which was successful.The endoleak was successfully resolved by placing a competitors excluder 32mm cuff.

• 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: 5882234
• Report Number: 3004753364-2016-00025
• Device Sequence Number: 1367165
• Product Code: MIH
• UDI-Device Identifier: 05055715611534
• UDI-Public: (01)05055715611534(17)180505(10)CP72830-1
• 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): 08/16/2016

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: 05/05/2018
• Device Model Number: SG-HBB-31-111-80-12
• Device Lot Number: CP72830-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2016
• Initial Report FDA Received Date: 08/17/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 86 YR