MAUDE Adverse Event Report: LOMBARD MEDIAL LTD AORTIX AAA FLEXIBLE STENT GRAFT SYSTEM; ENDOVASCULAR STENT GRAFT

Model Number SG-HBB-27-96-63-12

Device Problem No Apparent Adverse Event (3189)

Patient Problems Aneurysm (1708); Death (1802)

Event Date 05/20/2015

Event Type  Death  

Event Description

The original procedure was performed on a very small (b)(6) female patient, weight (b)(6) who had been admitted to the hospital the morning of the procedure with a chronically symptomatic aneurysm and who was unsuitable for open repair of her aaa.Her symptoms included gastric obstruction secondary to the aaa.Her aortic anatomy involved an unfavourable aneurysm neck that was angled 80 degrees, included a dissection flap, was highly conical and had an overall length of less than 15mm.The diameter of the aneurysm was 12cm an access vessels had luminal diameters of 6mm which is smaller than the size of the aorfix delivery system.A decision was taken to treat the patient's aneurysm as an emergency an aorfix was chosen because of the high neck angle but despite the short and conical neck lying outside the indications for the implant.Notes on the patient were not available but after completion of the surgery the patient's family revealed a history of extensive peripheral arterial disease.(internal reference number: (b)(4)).During the procedure aorfix was placed as juxta-renally as possible to maximise the available neck.During the procedure it was noted that the right external iliac artery had been perforated and eventually this was ligated after attempts failed to re-line the vessel with covered stents.A fem-fem bypass graft was placed to maintain perfusion of the right femoral artery system.Great difficulty was encountered with several aspects of the surgery indicated by the overall procedure lasting over 15 hours.The surgeon commented that the evar part of the procedure lasted approximately 3 of the 15 hours and the remaining 12 hours involved resolving occlusions and perforations to the vasculature consequent to the very poor condition of the patient's vessels.A completion angiogram showed that there was a type ia endoleak which reduced on repeat ballooning but was not fully resolved.A total of 370ml of contrast agent was administered to the patient.The patient survived the procedure but died on the itu 3 days post procedure from renal failure consequent to contrast nephrotoxicity.The surgeon commented that aorfix performed perfectly but unfortunately the patient's condition was too far advanced to be resolved with surgery.

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.Ifu review: lombard medical's ifu warns of patient and device selection, and consideration of the risk/benefits with regards to certain characteristics of patient's anatomy.This was an off-label case, and the patient dies of renal failure consequent to contrast nephrotoxicity.Risk analysis review: (b)(6) risk analysis has been reviewed and as this was an off-label case, it doesn ot fall within (b)(6) risk analysis which makes an assumption that the patient has been selected in accordance with the indications and contra-indications for use.The complaints log identifies 8 complaints detailing a patient death.However, these have all been determined not to be device related and were as a result of patient related issues.None of these cases were related to renal failure consequent to contrast nephrotoxicity.(b)(6) has performed over (b)(6) cases to date.The current reported event rate for death is 0.16%.The risk / benefit remains acceptable however lombard medial will continue to track and trend in accordance to quality system procedure.(b)(6) now intends to close this complaint.(internal reference number:(b)(4) mdr#: 3004753364-2015-00015).

• Brand Name: AORTIX AAA FLEXIBLE STENT GRAFT SYSTEM
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDIAL LTD; didcot, oxfordshire OX11 7HG; UK OX11 7HG
• Manufacturer Contact: 4 trident park; didcot, oxfordshire ; 235750800
• MDR Report Key: 4837650
• MDR Text Key: 5904190
• Report Number: 3004753364-2015-00015
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2017
• Device Model Number: SG-HBB-27-96-63-12
• Device Lot Number: CP59307-1
• Other Device ID Number: 01050557156089541717021210CP59
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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; Hospitalization
• Patient Age: 85 YR
• Patient Weight: 40