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

Catalog Number VAMF3838C150TE

Device Problem Inaccurate Delivery (2339)

Event Date 11/18/2013

Event Type  Injury  

Event Description

Additional information was received.The false lumen perfusion was reported to have resolved due to spontaneous thrombosis.

Event Description

A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a chronic type b thoracic aortic dissection.The stent graft was placed in zone 3 and distal to the entry tear.The proximal aortic neck was 35 mm in diameter and 25 mm long.The smallest diameter of the true lumen was 13 mm, and the maximum diameter of the aorta at this level was 40 mm.The distal aortic neck was 38mm in diameter.The minimum diameter of the main access vessel was 10 mm.The false lumen started in zone 3 and extended distally to between the celiac axis and renal arteries.The procedure was successful with no reported adverse events or technical observations.Post-operative imaging was not done prior to discharge from the hospital.It was reported that ct with contrast one month post-evar indicated perfusion of the false lumen.The smallest diameter of the true lumen was 23 mm, and the maximum aortic diameter at this level was 50 mm.The false lumen was patent at the level of the stent graft, and partially thrombosed distal to the stent graft.The dissection had not progressed.The source of the false lumen perfusion was noted to be residual flow over the primary entry, with the stent graft not covering the primary entry.Placement of the stent graft distal to the entry tear was unintentional; the physician believed that the entry tear had been covered.The investigator assessed the event to not be related to the device or the procedure.The patient is being monitored.No additional clinical sequelae were reported, and the patient is fine.

Manufacturer Narrative

(b)(4).Results, conclusions: stent graft misplacement.Insufficient information; cause is unknown.

• 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: ludmila voulfson ; 3576 unocal place; santa rosa, CA 95403 ; 7075661229
• MDR Report Key: 3613512
• MDR Text Key: 4342062
• Report Number: 2953200-2014-00177
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2014

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: 09/06/2015
• Device Catalogue Number: VAMF3838C150TE
• Device Lot Number: V04112233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 02/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2014
• Date Device Manufactured: 09/06/2013
• 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 Age: 00073 YR
• Patient Weight: 84