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

Device Problems Leak/Splash (1354); Occlusion Within Device (1423); Inaccurate Delivery (2339); Folded (2630)

Patient Problems Stroke/CVA (1770); Death (1802); Fever (1858); Unspecified Infection (1930); Ischemia (1942); Paralysis (1997); Rupture (2208); Claudication (2550); Vascular Dissection (3160)

Event Date 10/16/2012

Event Type  Death  

Event Description

The following information was obtained from a journal article.Long-term experience with endovascular therapy of the descending thoracic aorta.Jan raupach, jan vojacek, miroslav lojik, jan harrer, vendelin chovanec, alexander ferko, petr hoffmann, pavel ry¿ka, ondrej renc, antonin krajina.10.2478/s11536-012-0117 the following adverse events were observed: infection, stroke, death, dissection, infolding, endoleak, ischemia, conversion, occlusion, claudication, fever, paralysis.No further information is available for this event.Background: to review single centre experience of endovascular treatment of descending thoracic aorta.Methods: between may 1999 and september 2012, 72 patients were treated overall (53 men, 19 women, mean age 60.1 years) for degenerative aneurysms (n = 5), ruptured aneurysms (n = 4), aortic ulcers (n = 8), infected aneurysms (n = 4), type b aortic dissections (n = 23), and traumatic aortic injuries (n = 28).Results: the technical success rate was 98.6%, 30-day mortality was 8.3%, 1-year mortality was 13.8%, and overall mortality was 22.2%.Mortality caused by the treatment of aortic diseases was 6.9%.Permanent stroke occurred in 1 patient, and paraplegia developed in 1 patient.In a group of 23 patients whose left subclavian artery (lsa) was covered, claudication of the left upper extremity developed in 2 cases.Conclusions: endovascular therapy offers a very effective and less invasive alternative to the surgical approach for a wide range of the thoracic aortic disease.The main advantage of using tevar seems to be in acute conditions when a stent graft stabilizes the aorta and prevents further bleeding and organ ischemia.Regular follow-up is mandatory for early recognition of specific tevar complications.

Manufacturer Narrative

Date of death is unknown.(b)(4).Evaluation, results: inherent risk of procedure (infection, stroke, death, dissection, infolding, endoleak, ischemia, conversion, occlusion, claudication, fever, paralysis, inaccurate delivery), (unknown cause of event), unapproved use of device (infected aneurysm, pre-op rupture); evaluation, conclusion: (unknown cause of event), known inherent risk of a procedure, inherent risk of procedure (infection, stroke, death, dissection, infolding, endoleak, ischemia, conversion, occlusion, claudication, fever, paralysis, inaccurate delivery), off ¿label, unapproved or contraindicated use (infected aneurysm, pre-op rupture).

• Brand Name: TALENT TAA
• 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: 3623212
• MDR Text Key: 4174007
• Report Number: 2953200-2014-00220
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P070007
• 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: 01/17/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/11/2014
• 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): Death
• Patient Age: 00060 YR