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

Model Number SG-HBB-27-126-63

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 04/23/2015

Event Type  Injury  

Event Description

The original procedure was performed on (b)(6) 2015 with good top end place in irregular and angulated neck.No leaks were detected at final scan.The pt was admitted for groin pain related to a haematoma (not graft related) and was subsequently scanned.Venous flow and with poor quality but the scan showed a significant type 1a leak.After discussions between the proctor and the vascular surgeon, the vascular surgeon decided that the graft would be explanted.Type 1a endoleaks results from inadequate sealing at the site of the graft attachment.In this case, partial thrombus and calcification was present in an irregular proximal neck with a 90 degree angle, which may have contributed to the sealing site becoming compromised.The symptoms the pt was experiencing were related to the haematoma and unrelated to the type 1a endoleak.((b)(4)).

Manufacturer Narrative

(b)(4).Aorfix instructions for use contains info regarding pts with highly angled necks and tortuosity.It states within the ifu that the position end of the stent graft should be monitored particularly when the device is being implanted into a tortuous vessel or a highly angled neck.There is no info to suggest malfunction of the implant.The irregular, highly angulated neck within the pt's anatomy has led to the type 1a endoleak.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 info to suggest that the device has not met the final release criteria.Lombard medicals risk analysis has been reviewed and type 1a endoleak is identified in the risk analysis.Causes listed are device related, however in this case it is believed that pt factors which include partial thrombus and calcification an irregular proximal neck has led to the occurrence of the type 1a endoleak.There is no info to suggest a device malfunction and no further update to the risk analysis is required.The risk/benefit remains acceptable however lombard medical will continue to track and trend in accordance to quality system procedures.Lombard medical now intends to close this complaint.

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD; didcot, oxfordshire OX11 7HJ; UK OX11 7HJ
• Manufacturer Contact: 4 trident park; didcot, oxfordshire ; 235750800
• MDR Report Key: 4774431
• MDR Text Key: 5796763
• Report Number: 3004753364-2015-00012
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2016
• Device Model Number: SG-HBB-27-126-63
• Device Lot Number: CB57494-1
• Other Device ID Number: (01)05055715608770(17)161124(1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention