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

Model Number SG-HBB-24-126

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 04/01/2015

Event Type  Injury  

Event Description

The original procedures was performed on (b)(6) 2011 ((b)(4)).On (b)(6) 2015, a re-intervention was performed to treat a type 1b endoleak by re-aligning the ipsilateral leg with an 81-12 (total length 121mm) to land proximal at site of 12mm socket area of main graft.Case review: the original procedure was performed on (b)(6) 2011 ((b)(4)).It has been stated on the original evar planning sheet that on completion of surgery there was an undefined endoleak present in the right limb.Comments also stated that the diameters of both common iliac arteries were outside ifu indications.The planned re-intervention was performed on 04/01/2015 to address an issue with the 20mm aorfix limb that had lost wall apposition causing a type 1b endoleak.This occurred due to common iliac artery disease progression causing it to become aneurysmal.(b)(4) graft was implanted.The endoleak was successfully resolved.((b)(4)).

Manufacturer Narrative

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 specification.There is no info to suggest that the device has not met the final release criteria.From a review of the ifu, the warnings and precautions state: long-term efficacy of aorfix has not been established.Consequently, pts should be followed up routinely, and monitored for endoleak.Aneurysm growth and evidence of device migration.Common iliac arteries of aneurysmal or near aneurysmal proportions may lead to an endoleak.Potential adverse events related to the procedure or device malfunction include, but are not limited to endoleak; the risk analysis has been reviewed and type 1b endoleak is listed in lombard medical's hazard analysis.No further updates required.In this case, type 1b endoleak is a result of continuing aneurysm disease leading to dilation of the neck, which falls within the clinical expectations.The risk/benefit remains acceptable however lombard medical will continue to track and trends in accordance to quality system procedures.There is no info to suggest malfunction of the implant.Lombard medical not intends to close this complaint.

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
• Type of Device: ENDOVASCULAR STENT RAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD; didcot, oxfordshire OX11 7HJ; UK OX11 7HJ
• Manufacturer Contact: 4 trident park; didcot, oxfordshire ; 235750800
• MDR Report Key: 4774430
• MDR Text Key: 5950651
• Report Number: 3004753364-2015-00011
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 05/14/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2013
• Device Model Number: SG-HBB-24-126
• Device Lot Number: AZ23592-1
• Other Device ID Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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