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

Model Number SG-HBB-24-96

Device Problem Malposition of Device (2616)

Patient Problem Aneurysm (1708)

Event Date 11/04/2014

Event Type  Injury  

Event Description

The original procedure was performed on (b)(6) 2014.Although the working length for the contralateral leg was 65mm, the 73mm was chosen and deployed slightly occluding the left internal iliac artery.The physician tried to push up the contralateral leg by using a balloon, but no success.Right internal iliac artery was blocked by blood clots.The patient was closely monitored and the physician opted to withhold a treatment.Upon completion of the procedure, the aneurysm was successfully excluded.Implanted devices: 1).Sg-hbb-24-96; lot: bw50211-1; exp.Date: 04/10/2016; mfr date: apr 2014.2) sg-hbl-73-14; lot: bz49432-1; exp.Date: 05/26/2016; mfr date: may 2014.3) sg-hgl-56-12; lot: bz 49047-1; exp.Date: 04/17/2016; mfr date: apr 2014.

Manufacturer Narrative

Udi#: (b)(4).According to the complaint description, the contralateral leg length should have been 56mm and not 73mm.The oversizing and misplacement of the contralateral leg may have contributed to the limb occlusion.The ifu states: "each stent graft must be ordered in a size appropriate to fit the patient's anatomy.Physicians should use adequate diagnostic techniques, including ct imaging, to evaluate fully individual needs of the patient".No further updates required.The risk mgmt file was reviewed and internal iliac occlusion is listed in the hazard analysis under section c 4.2 - misplacement of contra-lateral limb.No further update is required.There is no info to suggest the device has not worked as intended.

• 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: 4360205
• MDR Text Key: 5115541
• Report Number: 3004753364-2014-00022
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2016
• Device Model Number: SG-HBB-24-96
• Device Lot Number: BW50211-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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): Disability
• Patient Age: 77 YR