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

Model Number SG-HBB-24-126-63-20

Device Problem No Apparent Adverse Event (3189)

Patient Problems Aneurysm (1708); Death (1802); Vascular Dissection (3160)

Event Date 10/20/2015

Event Type  Death  

Manufacturer Narrative

Further investigation is in process and a final report shall be filed as per its conclusion.

Event Description

The original procedure was performed on the (b)(6) 2015.The information received on the same day details the following: the case was not successfully completed.The patient died during the procedure.This was not graft related.A small induced dissection in the contralateral exploratory caused a cardiac event and pressure drop.Despite 70 minutes of reanimation and momentary pressure increase and emergency measures, the patient could not be saved.Further information received on the (b)(4) 2015 details the following: the main body was implanted without issues.It was not possible to cannulate the contra lateral side.The left common iliac artery was very tortuous and it was not possible to straighten with a stiff wire.A 8f flexor sheet and a wire were used to cross an angulated section.This particular step may have caused the dissection.A converter was implanted to prevent the loss of blood and to stop the bleeding.Implants used in this case: model number lot number expiry date manufacture date udi 1) sg-hbb-24-126-63-20 1) cp58496-1 1) 06 jan 2017 1) 06 jan 2015 (b)(4) 2) sg-hbc-25 2) cc57113-1 2) 12 nov 2016 2) 12 nov 2014 (b)(4).

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 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: original evar was performed on (b)(6) 2015.The main body was implanted without issue.However, during the procedure, the physician stated that it was not possible to cannulate the contralateral side.The left common iliac artery was very tortuous and it was not possible to straighten with a stiff guide wire.An 8f flexor sheath and a guide wire were used to cross the angulated section.It is believed that the dissection may have been caused whilst performing this part of the procedure.From a review of the patient's sizing sheet, it is clear that the left common iliac was aneurysmal (up to 30mm) with partial calcification and tortuous vessels.It is possible that the dissection was caused when attempting to maneuver through the common iliac.A convertor device was implanted following identification of the dissection in an attempt to stop the loss of blood from the dissection.The converter device has not caused or contributed to this event and was implanted in an attempt to resolve the issue and stabilize the patient.It has been reported that the patient had poor cardiac constitution.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 related to the procedure or device malfunction include, but are not limited to: death, cardiac complications e.G.Myocardial infarction, blood loss warnings and precautions state: care must be taken in those patients where the aneurysm proximal neck, distal landing zones, or iliac arteries are calcified and tortuous.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 the analysis.Eg: bowel, stroke, respiratory.It has been reported that the patient was in poor cardiac constitution and this event is related to the surgery performed.The current event rate for patient death reported within lombard medical complaint system is 0.16%, which is within clinical expectations.Conclusion: the risk / benefit remains acceptable however lombard medical will continue to track and trend in accordance with quality system procedures.Lombard medical now intends to close this complaint.

• 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: 5186958
• MDR Text Key: 29801456
• Report Number: 3004753364-2015-00029
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 05055715606653
• UDI-Public: (01)05055715606653(17)170106(10)CP58496-1
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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: Physician
• Device Expiration Date: 01/06/2017
• Device Model Number: SG-HBB-24-126-63-20
• Device Catalogue Number: NOT APPLICABLE.
• Device Lot Number: CP58496-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 10/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR