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

Model Number	SG-HBB-27-111-80-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other aorfix devices used in the procedure: plug in leg information: model no.Sg-hbl-90-14, lot no.Cl65098-1, manufacture date.20 jul 2015, expiry date.19 jul 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.In this case, the patient had a highly angulated proximal neck of 100° (off-label).A distal extender was ordered and shipped for this case but not used as originally planned.
Event or Problem Description
On (b)(6) the physician inserted the main body by the right approaching and deployed the contra-lateral socket.After cannulating the contra-lateral limb, he deployed the ipsi-lateral limb overall and used a reliant balloon catheter to better land the device at the external iliac artery.After the insertion of the contra-lateral limb, it was deployed and moulded around the external iliac artery.Thereafter, all the devices were moulded with use of a balloon catheter.The angiography revealed a type ia endoleak.Therefore, he added an excluder cuff to resolve it and this time, the angiography revealed a type iv endoleak.The procedure was finished.He decided to follow-up the patient.On (b)(6) the physician confirmed an endoleak again with use of ct.In order to identify details, he performed an angiography and determined that it was a type ib endoleak at the right distal portion.Additional information as of (b)(6) 2016 - re-intervention the angiography revealed a type ib endoleak, because the sealing zone of the fishmouth trough at the right distal side was only 5 mm or so.Therefore, the physician placed (b)(4) as an additional device to the right ipsi-lateral limb.Thereafter, 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: 5586362
• Report Number: 3004753364-2016-00010
• Device Sequence Number: 875879
• Product Code: MIH
• UDI-Device Identifier: 05055715608664
• UDI-Public: (01)05055715608664(17)170812(10)CP65606-1
• 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): 04/15/2016

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: 12/08/2017
• Device Model Number: SG-HBB-27-111-80-14
• Device Lot Number: CP65606-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2016
• Initial Report FDA Received Date: 04/19/2016
• 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
• Patient Age: 82 YR