MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number VAMF4040C200TE

Device Problems Leak/Splash (1354); Difficult To Position (1467); Inaccurate Delivery (2339); Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Sepsis (2067); Injury (2348); Respiratory Failure (2484)

Event Date 10/22/2013

Event Type  Death  

Event Description

A valiant captivia stent graft system was implanted for the endovascular treatment of a 69 mm diameter aneurysm of the descending thoracic aorta.The length of the non-aneurysm proximal neck was 30 mm, proximal diameter of non-aneurysm aortic neck was 36 mm, distal diameter of non-aneurysmal aortic neck was 32 mm, length of distal neck was 35 mm, and the minimum diameter of the main access vessel was 10 mm.The shape of the distal neck was parallel sides.At the end of the index procedure a left ilio-femoral thrombectomy was performed.It was reported that seven days post-operative, a proximal type i endoleak was observed coming from the valiant device, approximately 5 cm from the origin of the left subclavian artery.The endoleak was left uncorrected.The physician commented that the deployment of the proximal part of stent graft was difficult due to the angulation of thoracic aorta, by a patient who had been treated in the past with a aaa bifurcated stent graft.The deployment was performed slightly too low and will require the placement of a proximal cuff, until the origin of lsa.In addition, difficult maneuvers caused an ascension of the left limb of aaa stent gr aft which needs to be replaced.No clinical sequelae were reported and the patient is fine.

Event Description

Additional information was received.The investigator's assessment of the event at implant is not device but procedure related.

Event Description

Additional information was received.A secondary intervention was performed and another manufacturer¿s stent graft with a smaller diameter was implanted however, the proximal type i endoleak did not resolve.The patient's descending thoracic aorta was extremely angulated.Another secondary procedure was performed.The physician implanted another additional stent graft with better sizing in order to pass through the elbow of the descending thoracic aorta resolving the endoleak.

Event Description

Additional information was received.It was reported that a type iii endoleak was observed at the aortic isthmus.The subtype of endoleak was not reported and no intervention was performed.No clinical sequelae were reported and the patient is being monitored.

Manufacturer Narrative

(b)(4).Evaluation, results: inherent risk of procedure (endoleak, inaccurate delivery), patient's condition affected effectiveness of device (anatomy related; angulated proximal aortic neck); evaluation, conclusion: known inherent risk of a procedure (endoleak, inaccurate delivery), device failure/lack of effectiveness related to patient condition (anatomy related; angulated proximal aortic neck).

Event Description

Updated information received.The previously reported type iii endoleak was updated to a proximal type i endoleak.Another manufacturer¿s device was implanted proximal to the valiant stent graft.The investigator assessed that the events were related to the device and related to the procedure.

Manufacturer Narrative

Additional information was received and it was reported that the type ia endoleak was observed in 2 follow up visits.A pet scan showed no anomaly on the tevar.It was reported that the patient expired.The cause of death was reported as acute respiratory failure due to severe sepsis (urinary and pulmonary primary sources, with a doubt about endocarditis), and a deterioration of the patient's general condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway, CA ; 7075912586
• MDR Report Key: 3567680
• MDR Text Key: 4072270
• Report Number: 2953200-2014-00043
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/01/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2015
• Device Model Number: VAMF4040C200TE
• Device Catalogue Number: VAMF4040C200TE
• Device Lot Number: V04111296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 01/10/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 04/05/2018
• Supplement Dates FDA Received: 03/26/2014; 07/09/2014; 03/02/2015; 04/03/2017; 05/01/2018
• Date Device Manufactured: 09/10/2013
• 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
• Patient Age: 00082 YR
• Patient Weight: 81