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

Model Number SG-HBB-24-96-63-16

Device Problem Hole In Material (1293)

Patient Problems Aneurysm (1708); Death (1802); Rupture (2208)

Event Date 10/21/2015

Event Type  Death  

Manufacturer Narrative

Dhr review: a full review of the device history records 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 devices have not met the final release criteria.Video review: additionally review of an in process video taken after loading of the main body and proximal extender devices was carried out.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.Case review: original evar was performed on (b)(6) 2015.The procedure was successful and no endoleaks were reported on the final run.During the procedure, a leg delivery system became kinked in the anatomy whilst trying to advance to the delivery location.There was no impact to the patient and a gore limb was implanted in place of the aorfix limb.A cook distal extender was also used to extend the limb.Update received on 22 oct 15 reported that a re-intervention was performed on (b)(6) 2015 as the patient's aneurysm had ruptured.A type 3b endoleak was identified during the re-intervention but was not able to be resolved.The patient died the same day.Event 1: kinked leg delivery device.The hbl device has kinked in tortuous anatomy upon advancement to the delivery location.The leg device was not returned to lombard medical and therefore it is not possible to inspect the delivery system.The overall diameter of the leg delivery system sheath is 20fr.The gore leg delivery system sheath overall diameter is minimally 16fr; therefore as it is lower profile, it was able to advance to the delivery location.Lombard medical has active development programs to make the delivery systems lower in profile.Event 2: ruptured aneurysm / death (re-intervention).Update received on 22 oct 15 reported that a re-intervention was performed on (b)(6) 2015 to address a ruptured aneurysm.A type 3b endoleak was identified during the re-intervention but was not able to be resolved.An open repair was not performed as the patient's family expressed that this was not their wish.The patient died the same day.An autopsy was performed and the physician observed that there was a hole in the "crotch" [flow divider] area of the main body graft.The physician stated the hole could possibly have been generated during the catheter and wire manipulations for the cross over cannulation attempts during the primary evar.The patient had a highly angulated proximal neck (approx.84 degrees).In addition, the right common iliac had some tortuosity and angulation right at the aortic bifurcation.The patient also had moderate calcification in the vessel.There is no information to suggest malfunction of the implant.The dhr review and video reviews are acceptable, and therefore confirm that all inspection and manufacturing activities met specifications.Ifu review: the ifu has been reviewed as per sections described below.Potential adverse events: potential adverse events related to the procedure or implant malfunction include, but are not limited to: death; loss of stent graft function arising from, for example, improper component placement or deployment, component migration, occlusion, infection, loss of integrity requiring surgical revision, perforation and endoleak; vessel damage, for example, dissection, plaque disruption, rupture, thrombosis, occlusion and fistulae.The ifu states within the implant procedure: inaccurate placement or an inadequate seal zone may result in an increased risk of leakage into the aneurysm or migration of the stent graft.Do not use excessive force to advance or withdraw the delivery device when resistance is encountered.If the delivery device kinks during insertion, do not attempt to deploy the stent graft component; remove the device and replace it with a new one.Stent graft components cannot be replaced or drawn back into the delivery device, even if the stent graft component is only partially deployed.Exercise care in handling and delivery techniques to help prevent vessel rupture.Patient device and selection states: 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: 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.Follow-up imaging states: patients with particularly challenging anatomy, including those with aortic neck anatomy that lies outside the indications of this ifu, patients with trapezoidal necks with a diameter change of 5mm or more over 15mm, those in whom the proximal landing zone could not be juxta-renal, particularly if the lowest part of the fishmouth is 8mm or more distal to the distal renal artery, those with high levels of calcified plaque at the transition of the aortic neck to the aneurysm sac and those in whom barb fracture has been detected should be followed diligently with consideration given to more frequent follow-up.Late migration, sac expansion, aneurysm rupture and fracture have occurred in such patients.' risk analysis: event 1: kinked delivery system.Lombard medicals hazards risk analysis has been reviewed and unable to advance delivery system to delivery location is listed in lombard medical hazard analysis section f.1.2.No further update is required.The current event rate for being unable to advance delivery system to delivery location is which is within clinical expectations.Event 2: ruptured aneurysm / death (re-intervention).Lombard medical's hazards risk analysis has been reviewed and type 3b endoleak is listed in lombard medical hazard analysis section a.4.No further update is required.The current event rate for type 3b endoleak remains within clinical expectations.In this case, the type 3b endoleak may not have been identified in the original procedure and the patient's aneurysm ruptured.The current event rate for patient death reported within lombard medical complaint system is (b)(4), which is within clinical expectations.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.Device was not returned to the company.

Event Description

Event 1: kinked leg device during insertion.Event 2: ruptured aneurysm / death (re-intervention).Evar was performed on (b)(6) 2015.The case was a challenging, high-angle evar.Bilateral cutdowns were performed and main body aorfix was inserted into the left iliac and deployed at the renal arteries.After cannulating the evar graft from the right side, a couple attempts were made to deliver an aorfix contralateral limb.The contralateral limb would not pass and was removed from the body.Upon removal, it was noticed that the aorfix contra limb had kinked trying to deliver it.A gore limb was then used to graft the right common iliac from the aorfix flow divider down to the iliac bifurcation and a cook limb extension was used to extend further into the left common iliac.Everything was then ballooned and a final angio run was performed.No endoleaks were reported at that time.Physician called at 12:58am ((b)(6) 2015) stating that the patient's aneurysm had ruptured.Patient had a ct confirming the aortic rupture and was currently in the hybrid suite being treated.Physician then spoke with (b)(6) to discuss next treatment steps.Patient outcome is unknown at this time.Update received on 22 oct 15: endovascular re-intervention was performed on (b)(6) 2015 treat the rupture, patient passed away same day.An endoleak was observed during the endovascular re-intervention but could not be resolved.The family members expressed that they did not want their relative to undergo an attempt at an open surgical repair of the endoleak an autopsy was performed and the physician observed that there was a hole in the "crotch" [flow divider] area of the main body graft she stated the hole could possibly have been generated during the catheter and wire manipulations for the cross over cannulation attempts during the primary evar.

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT
• 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: 5236416
• MDR Text Key: 31624785
• Report Number: 3004753364-2015-00030
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 05055715606998
• UDI-Public: (01)05055715606998(17)160207(10)BK47658-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/07/2016
• Device Model Number: SG-HBB-24-96-63-16
• Device Lot Number: BK47658-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2014
• 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): Death; Required Intervention