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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984); Vascular Dissection (3160)
Date of Event	03/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Distal extender information: model no.Sg-hde-12-82, lot no.Cm60920-1, manufacture date.16 mar 2015, expiry date.15 mar 2017.A full review of the device history records 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
Re-intervention performed on (b)(6) 2016 to treat persistant type 1a endoleak.Original evar performed on (b)(6) 2015.A) left iia occlusion, left eia dissection; b) minor type 1a endoleak.Original evar information: the main body was placed approaching from the left femoral artery for the abdominal evar following the ifu.After deploying the contra-lateral socket, the physician cannulated it.After the cannulation, he initiated deployment of the ipsi-lateral limb.Regarding the issue a), he attempted to cross over a catheter from the contra-lateral side toward the ipsi-lateral side for angiography.However, the angiography revealed nothing.Therefore, targeting around the right internal iliac artery, he deployed the device a bit lower, judging that there would be no problem while observing the 3d images taken before procedure.When trying to dock the proximal tip of the delivery system, the device was entrapped at the distal part of the ipsi-lateral side and the distal part migrated.The final angiography revealed that the left internal iliac artery was occluded.Regarding the issue b), the final angiography revealed a minor type 1a endoleak.A) although the physician attempted to push up the device with use of the dry seal sheath (gore (b)(4), 18 fr.), he found no change.When he tried pushing up the device with the sheath, he confirmed a dissection in the left external iliac artery.Then, he covered it with use of the epic vascular stent (boston scientific (b)(4), 10 - 100 mm).B) the patient will be followed up.The procedure was finished.Re-intervention information: (b)(6) 2016: type 1a endoleak was still remaining.(b)(6) 2016: re-intervention was performed.The physician performed a long inflation with a reliant balloon catheter, but type 1a was not resolved.He placed 2 cuffs (pxa 26mm) at the proximal neck, and then the type 1a endoleak was resolved.Currently, the left internal iliac artery is still occluded however there is no plan for re-intervention at this time.The patient will be followed up.

• 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: 5519193
• Report Number: 3004753364-2016-00008
• Device Sequence Number: 330748
• Product Code: MIH
• UDI-Device Identifier: 05055715606851
• UDI-Public: (01)05055715606851(17)170405(10)CP61316-1
• 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): 03/22/2016

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: 04/05/2017
• Device Model Number: SG-HBB-24-81-80-12
• Device Lot Number: CP61316-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2016
• Initial Report FDA Received Date: 03/23/2016
• 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