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

Model Number SG-HBB-24-96-80-14

Device Problem No Apparent Adverse Event (3189)

Patient Problems Aneurysm (1708); Myocardial Infarction (1969)

Event Type  Death  

Manufacturer Narrative

An investigation was conducted and the conclusion are as follows: 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 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.Case review: the original evar procedure was performed on (b)(6) 2015.A type 1a endoleak was present during the procedure however this was resolved by ballooning, implantation of a gore excluder cuff to increase radial force and finally a palmaz stent.It is reported that the proximal section of the palmaz extended across the origins of both renal arteries, above the aorfix stent graft, both renal arteries appeared patent on the final angiograhic runs.Further scans showed what the physician considered to be either a type 3 or type 4 endoleak.The decision was made by the physician to review at the 30-day follow up ct to assess the situation further.Type 4 endoleaks are common due to the patient heparinization during evar, and are expected to resolve within 30 days after surgery.Update received on 23 sep 15 reported that the patient later died (2 weeks post op) of mi (myocardial infarction).This was caused by the irreversible necrosis of heart muscle secondary to prolonged ischemia.The patient had a pre-existing medical condition and history of heart disease which the physician was aware of prior to the procedure.The patient was reviewed by cardiovascular surgeons and clearance to proceed was granted by the vascular surgeons.There is no information to suggest that aorfix has caused or contributed to this event.This was a high risk case.The clinician is not complaining and this event has been entered in lombard medical complaint system to allow assessment under medical device reporting and vigilance requirements.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.The stent graft has performed as intended.No further investigation is required.Ifu review: potential adverse events: potential adverse events related to the procedure or implant malfunction include, but are not limited to: death; patient and device 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).This device is not recommended in patients who: have or are suspected of having an active systemic infection; cannot tolerate imaging contrast agents, or have sensitivities or allergies to the stent graft system materials, antiplatelets or anticoagulants; have unstable angina; have had a myocardial infarction (mi) or cerebral vascular accident (cva) within 6 months prior to implantation; or exceed weight and/or size limits necessary to meet institution-defined imaging requirements.Specific patient populations states: the safety and effectiveness of the aorfix aaa flexible stent graft system has not been evaluated in patients who: have had a myocardial infarction (mi) within 6 months prior to implantation there was no report of mi prior to the case however the patient had a history of heart disease and required evaluation by cardiologists prior to the procedure going ahead.Risk analysis: this event falls outside of lombard medical's risk analysis which states that adverse events associated with all surgery will not be covered by this analysis.Eg: bowel, stroke, respiratory.Myocardial infarction would fall under an adverse event associated with surgery.In this case, the patient had a pre-existing medical condition and post procedure suffered a myocardial infarction (mi).The current event rate for patient death reported within lombard medical complaint system 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.

Event Description

The original procedure was performed on (b)(6) 2015 when the main body and limb were implanted as per ifu.The initial check revealed what appeared to be a type 1a endoleak.Re-ballooning the proximal end of the main body appeared to reduce the leak.The physician decided to implant a gore excluder aortic cuff to provide what he considered additional radial force, but the type 1a endoleak appeared to be present.A palmaz stent was implanted.The proximal section of the palmaz extended across the origins of both renal arteries, above the aorfix device.Further scans showed what the physician considered to be either a type 3 or type 4 endoleak.The decision was made by the physician to review the 30-day follow up ct to assess the situation further.Both renal arteries appeared patent on the final angiographic runs.Additional information received 23 sep 15 describes that the patient died from mi (myocardial infarction) 2 weeks post op.The physician said prior to the case that this patient had to be cleared by his cardiologist prior to the procedure.There was apparent history of heart disease.

• 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: 5146752
• MDR Text Key: 28135507
• Report Number: 3004753364-2015-00028
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 05055715607049
• UDI-Public: (01)05055715607049(17)170127(10)CP58498-1
• 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
• Reporter Occupation: Physician
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/27/2017
• Device Model Number: SG-HBB-24-96-80-14
• Device Lot Number: CP58498-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2015
• 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