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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other device used: model no.Sg-hbl-90-20, lot no.Cl66783-1, manufacture date.09 sept 2015, expiry date.08 sept 2017.A full review of the device history records for the 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.The physician has stated that the patient presented a highly angulated, barrel shaped proximal neck.Both left and right common iliac arteries were aneurysmal with the presence of calcification.Respiratory failure was confirmed as the cause of death and is unrelated to the implanted devices (possibly procedure related).Remains implanted in patient.
Event or Problem Description
Event: type 1a and 1b endoleaks post procedure / re-intervention original evar was performed on (b)(6) 2017.The final angiography revealed a type 1a endoleak.Re-ballooning was performed using a reliant balloon catheter (medtronic (b)(4)).Only a type 4 endoleak remained.The original procedure was finished.Follow-up ct images were taken one week after the original procedure and revealed a type 1a endoleak.On (b)(6) 2017, the physician performed a re-intervention to resolve the type 1a endoleak by placing an excluder cuff (28.5mm, gore) it was also confirmed that a type 1b endoleak was present at the right common iliac artery.To resolve this, the physician placed another excluder cuff (23mm, gore).This did not resolve the type 1b endoleak, therefore another excluder cuff (23mm, gore) was also placed.Both the type 1a and 1b endoleaks were resolved.The procedure was finished without further issues.At the end of (b)(6) 2017 (exact date unknown), it was confirmed that the patient passed away from respiratory failure, unrelated to the device and possibly procedure related.

• 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: 6649512
• Report Number: 3004753364-2017-00006
• Device Sequence Number: 1150413
• Product Code: MIH
• UDI-Device Identifier: 05055715611534
• UDI-Public: (01)05055715611534(17)180420(10)CP72340-1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P11032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

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: 04/20/2018
• Device Model Number: SG-HBB-31-111-80-12
• Device Lot Number: CP72340-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 06/19/2017
• 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: Required Intervention
• Patient Age: 76 YR