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

Device Problem Inaccurate Delivery (2339)

Patient Problem Occlusion (1984)

Event Date 12/23/2012

Event Type  Injury  

Event Description

The following information was obtained from a journal article.Wang l, guo d, jiang j, shi z, fu w, wang y, severe compression of a bail out self expanding chimney stent for rescuing the miscoverage of left common carotid artery during tevar of a type b aortic dissection, annals of vascular surgery (2014), doi: 10.1016/j.Avsg.2013.09.007.A (b)(6) man who suffered from paraplegia due to type b aortic dissection was treated with a valiant stent-graft.However, attempts to gain secure proximal sealing resulted in an inadvertent coverage of the left common carotid artery by the endograft.The blood flow in the left common carotid artery was restored by a transcarotid smart control stent in a chimney fashion.Upon 6-month and 18-month follow up, ct scan showed that the chimney stent was severely compressed by the stent-graft, though the patient still remained neurologically asymptomatic.

Manufacturer Narrative

(b)(4).Evaluation, results: patient¿s condition affected effectiveness of device (pre-operative dissection), inherent risk of procedure (stent graft misplacement), (insufficient information; cause is unknown); evaluation, conclusions: device failure related to patient condition (pre-operative dissection), known inherent risk of a procedure (stent graft misplacement), (insufficient information; cause is unknown).

• Brand Name: VALIANT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• 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: 3633185
• MDR Text Key: 3989130
• Report Number: 2953200-2014-00285
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2014
• 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): Required Intervention
• Patient Age: 00054 YR