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

Model Number	SG-HBB-24-96-80-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was a persistent type 1a endoleak after implantation of the device which continued after secondary intervention and placement of aptus endoanchors.It is probable that the sac rupture was a direct consequence of the type 1a endoleak.A full review of the device history records 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.Projecting wires are present in every stent graft manufactured and implanted since 2006.The extent to which the projecting wires remain after implantation is in part a reflection of the extent to which the implanting physician follows the ifu and balloons the implant over its entire length.There is no information to suggest an issue with the device in this case and the aneurysm rupture is most likely to be as a result of the persistent type 1a endoleak which is unrelated to the wire loops observed.There is no information to suggest that the wire loops reported have caused or contributed to this event.Device partially explanted, not returned.
Event or Problem Description
Event: aneurysm rupture (re-intervention and partial explantation) it is understood from the report dated 21.3.2017 (21 mar 2017), that after implantation on (b)(6) 2015, a secondary intervention was performed using aptus endoanchors to treat a persistent type 1a endoleak on (b)(6) 2016.This re-intervention was not communicated.It is also understood that the type 1a endoleak persisted even after placement of the aptus endoanchors.The patient presented a ruptured aneurysm on (b)(6) 2016 and the proximal part of the endograft was removed and replaced by a polyester surgical graft with sutured anastomoses.It is understood that an explicit statement has been made that at the time of explantation, the prosthesis was completely sealed and had not led directly to the rupture.Images of the case have not been received for review but it seems probable that the cause of the rupture is the persistent type 1a endoleak.It is also understood that the surgical team noticed that the graft fabric of the endograft did not lie tightly against all of the wires rings which reinforce it and that some of the wires project away from the graft in small loops.This appears to be a coincidental observation and no linkage was observed or proposed between the projecting wire loops and the rupture.

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD.; 4 trident park; didcot, OX11 7HJ; UK OX11 7HJ
• MDR Report Key: 6489719
• Report Number: 3004753364-2017-00005
• Device Sequence Number: 86893
• Product Code: MIH
• UDI-Device Identifier: 05055715607056
• UDI-Public: (01)05055715607056(17)170421(10)CU61859-1
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

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: 04/21/2017
• Device Model Number: SG-HBB-24-96-80-16
• Device Lot Number: CU61859-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 04/13/2017
• 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: Life Threatening; Required Intervention