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

Device Problem Inaccurate Delivery (2339)

Patient Problems Stroke/CVA (1770); Death (1802); High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Date 03/10/2013

Event Type  Death  

Event Description

The following information was obtained from a journal article.Spinal cord ischemia after thoracic stent-grafting: causes apart from intercostal artery coverage.Burkhart zipfel, semih buz, mathias redlin, dietrich hullmeine, robert hammerschmidt, and roland hetzer.Ann thorac surg 2013;96:31¿8 the following adverse events were observed: death, stroke, hypertension.No further information is available for this event.Methods: in an 11-year period,stent-grafts were implanted in 406 patients for various aortic pathologic conditions.The mean age was 63 years (15-91 years) and 300 (74%) patients were men; 58 patients underwent staged thoracic stent-graft procedures.The length of aorta covered was between 75 and 584 mm (mean, 204 mm).Thoracoabdominal branched or fenestrated stent-grafts were implanted in 11 patients.The left subclavianartery was occluded in 161 patients (39%); this occurred in half of them (n = 78) after protective revascularization.Prophylactic cerebrospinal fluid (csf) drainage was used selectively in 4 cases; no neuromonitoring was used.Results: the incidence of sci was 2.7% (n = 11); 6 patients (1.5%) had major permanent deficits.Conditions that had a potential influence on sci were analyzed.Statistical correlation was found for previous conventional or endovascular abdominal aortic aneurysm repair (odds ratio [or], 4.8), coverage of the entire descending thoracic aorta (or, 3.6), and implantation of thoracoabdominal branched and fenestrated stent-grafts (or, 9.5).Individual analyses revealed other conditions that might have played a role, such as embolization into the segmental arteries, severe visceral ischemia, profound hemorrhagic shock, and heparin-induced thrombocytopenia.Conclusions: the incidence of sci is unexpectedly low despite extensive sacrifice of intercostal arteries.Extended coverage of the thoracic and thoracoabdominal aorta seems to have a higher risk, but other factors may contribute to the individual disaster.

Manufacturer Narrative

Date of death is unknown.(b)(4).Results: death, stroke, hypertension.Unknown cause of events.Conclusion: unknown cause of events.Death, stroke, hypertension.

• 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: 3651554
• MDR Text Key: 4195394
• Report Number: 2953200-2014-00348
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P070027
• 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: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• 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
• Date Manufacturer Received: 02/03/2014
• 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: 00066 YR