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

Model Number SG-HBB-27-96-80-16

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Calcium Deposits/Calcification (1758)

Event Date 12/18/2015

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 device was performed.This video acts as a record that the device meets the inspection requirements for a loaded implant.This video confirmed that the device was packed into the delivery system 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 physician experienced difficulty advancing the delivery system and therefore converted to vascular prosthesis implantation.The physician states that damage was observed in the tunica intima of blood vessels.An attempt was made to fix them.Following this, the physician switched to the external iliac artery approach, palpated it and found that the entire circumference of the vessel was calcified.At this point, the physician converted to vascular prosthesis implantation.There is no reported damage identified with the delivery system prior to use.From a review of the sizing sheet, the patient had a proximal neck angle of 69°, with access vessel diameter of 8.5mm and 8.7mm with the presence of calcification in both common iliac arteries.The aorfix delivery system is 22fr which is approximately a diameter of 7.3mm.With the presence of calcification in both common iliac arteries, this would have reduced the access diameter and therefore based on the information supplied; this is most likely the cause of why the physician had difficulty advancing the delivery system.The delivery system was returned to lombard medical for inspection.There were no obvious signs of damage.A review of all manufacturing records and inspection activities confirms that results have passed acceptance criteria; therefore, there is no information to suggest a device malfunction.Ifu review: indications for use state: the aorfix aaa flexible stent graft system is indicated for treatment of patients with abdominal aortic and aorto-iliac aneurysms having vascular morphology suitable for endovascular repair, including: adequate iliac or femoral access that is compatible with vascular access techniques, implants, and accessories.Common iliac landing zone diameters with a range of 9mm to 19mm.Implant procedure states: "exercise particular care in difficult areas, such as areas of stenosis, intravascular thrombosis, or in calcified or tortuous vessels.Consider performing serial dilatation or balloon angioplasty at the site of a narrowed or stenotic vessel, and then attempt gently to reintroduce the delivery device." potential adverse events related to the procedure or implant malfunction include, but are not limited to: insertion and other vascular access site complications for example infection, dissection, bleeding, pain, delayed healing, hematoma, dehiscence, seroma, cellulitis, nerve injury/damage, arteriovenous fistula; patient selection and treatment states: ensure that access vessels are capable of accepting the 22 fr and 20 fr delivery devices.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.Risk analysis: 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.Lombard medical has performed over (b)(4) cases to date and the current event rate for being unable to advance delivery system to delivery location remains 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.

Event Description

The patient was initially supposed to undergo abdominal evar by the right femoral artery approach.No abnormalities identified at pre-operative ct.The physician attempted to insert a main body device aligning with the egoist guidewire (asahi-intecc).However, the main body was entrapped with something and would not advance.Then, he inserted a dry seal (gore, 18 fr) as a trial device and it advanced smoothly without problem.Therefore, now he re-attempted to insert the main body again, but it would not advance.Finally, he attempted to insert a dry seal (gore, 22 fr), but the main body would not advance this time, too.Additional action taken by the physician: he observed damages in tunica intima of blood vessels.Then, he attempted to fix them.Following it, he switched to the external iliac artery approach, palpated it and found that it was with entire circumference of calcification.He gave up performing evar and changed to vascular prosthesis implantation.Proctor's comment: pre-operative ct revealed no abnormalities.I cannot assume the cause of this trouble.One of possible causes might be stiff blood vessels of the patient (b)(6) 2015 - since the evar switched to the vascular prosthesis implantation, i confirmed to be palpated by nature the vessels directly, the problem was nothing.Physician's comment: i'm not sure the reason but it may be an angle to insert the delivery system was bad.

• 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: 5382391
• MDR Text Key: 36461250
• Report Number: 3004753364-2016-00003
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 05055715609210
• UDI-Public: (01)05055715609210(17)170514(10)CP62787-1
• 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: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/14/2017
• Device Model Number: SG-HBB-27-96-80-16
• Device Lot Number: CP62787-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR