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

Model Number SG-HBB-31-111-80-12

Device Problem Difficult to Advance (2920)

Patient Problem Aneurysm (1708)

Event Date 07/13/2015

Event Type  Injury  

Manufacturer Narrative

Dhr review: 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 information to suggest that the device has not met the final release criteria.Video review: additionally, a review of an in process video taken after loading of the main body and proximal extender devices was reviewed.This video acts as a record that the device meets the inspection requirements for a loaded implant.This video confirmed that the devices were packed into the delivery systems in accordance to company work instruction 211, inspection of packed sg-hbb and sg-hpe devices.Delivery system inspection: on receipt of the delivery system returned to lombard medical, the device was initially inspected.There was no evidence to suggest transit damage i.E.No external damage to packaging.There was no evidence of damage within the internal packaging or to the delivery system.There is no evidence to suggest device malfunction.Case review: (including sizing sheet and scan review where required): lombard medical's main body delivery system has a 22fr sheath which equates to a diameter of approximately 7.33mm.From review of the sizing sheet for this case, it appears that the patient has 10 -11mm access vessels and therefore the delivery system should have been able to negotiate the vasculature to the delivery location.The clinician however had an aorfix generation ii delivery device which does not include a hydrophilic coating, which may have been the reason resistance was felt during insertion.After several failed attempts with aorfix, the clinician selected a competitor device with a 20fr sheath which equates to a diameter of approximately 6.66mm with a hydrophilic coating.Due to the competitor device being narrower and including a hydrophilic coating on the sheath, the delivery device was able to negotiate the vasculature and the device was successfully implanted.A review of all manufacturing records and inspection activities confirms that results have passed acceptance criteria.There is no information to suggest a device malfunction.Lombard medical launched the generation iii aorfix device in (b)(4) in q1 2015.The generation iii device includes a hydrophilic coating which reduces the risk of vessel damage and makes negotiation of the vasculature easier.Ifu review: patient and device selection states that inappropriate patient or device selection may result in poor device performance.Patients should be assessed for suitability by the prescribing physician who should take into account their knowledge of aaa surgery and endovascular aneurysm repair (evar) including but not limited to the list below: access vessel diameter, vessel morphology and delivery device diameter should be compatible with vascular access techniques (femoral cutdown or percutaneous).Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the device or pose a risk of increased device complications.In patients with narrow access vessels, careful use of dilation, stenting or iliac conduits may allow introduction of the device.Patient selection and treatment states: ensure that access vessels are capable of accepting the 22 fr and 20 fr delivery devices.Specific patient populations states the safety and effectiveness of the aorfix aaa flexible stent graft system has not been evaluated in patients who: have arterial access that is not expected to accommodate the diameter of the delivery device as a result of size or tortuosity.Risk analysis: lombard medicals risk analysis has been reviewed and access failure is listed in it.No further update is required.(b)(4).Lombard medical has introduced a generation iii delivery system which includes a hydrophilic coating which makes access easier in patients with tortuous anatomy.Conclusions: 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 file.

Event Description

The original procedure was performed on the (b)(6) 2015.When the main body delivery system (22fr) was introduced into the patient's body by 15-20cm along with the aes guide wire (cook) to the left cfa, the delivery system was stuck.Guide wire was changed to the lunderquist (cook) followed by another attempt to advance the delivery system, but the status did not change.The physician tried to insert a competitor delivery system 18fr to the target region as a dummy sheath, it was able to advance to the target region.The sheath was withdrawn and the hbb delivery system was inserted again, but it could not advance to the target portion.The physician finished the procedure with endurant stent grafts (medtronic) instead of the hbb.

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD.; 4 trident park; didcot, oxfordshire OX11 7HJ; UK OX11 7HJ
• Manufacturer (Section G): LOMBARD MEDICAL LTD.; 4 trident park; didcot, oxfordshire OX11 7HJ; UK OX11 7HJ
• Manufacturer Contact: bianca sampaio ; 4 trident park; didcot, oxfordshire OX11 -7HJ ; UK OX11 7HJ ; 0123575087
• MDR Report Key: 5046791
• MDR Text Key: 24756579
• Report Number: 3004753364-2015-00025
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 05055715630795
• UDI-Public: (01)05055715630795(17)160728(10)BW51817-1
• 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
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/28/2016
• Device Model Number: SG-HBB-31-111-80-12
• Device Lot Number: BW51817-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR