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

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Inaccurate Delivery (2339)

Patient Problems Pulmonary Embolism (1498); Aneurysm (1708); Death (1802); Occlusion (1984); Paralysis (1997); Renal Failure (2041); Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 02/01/2014

Event Type  Death  

Event Description

Medtronic received the following information obtained from the journal article entitled: reintervention after thoracic endovascular aortic repair of complicated aortic dissection.Elsa m.Faure, md, ludovic canaud, md, phd, camille agostini, md, roxane shaub, md,gudrun böge, md, charles marty-ané, md, phd, and pierre alric, md, phd.J vasc surg 2014;59:327-33.Valiant and talent thoracic stent grafts were implanted in patient's for the endovascular treatment of complicated chronic aortic dissection, aortic aneurysm >55 mm, rapid aneurysmal enlargement or impending rupture (>5mmover 6 months), rupture, saccular aneurysm >20 mm, malperfusion syndrome, or intractable chest pain under medical therapy involving the descending thoracic aorta between october 2000 and december 2011 in zone 2 and zone 3.Vessel morphology was reported as there were some patient¿s with short proximal landing zone (<(><<)>20 mm), tortuous seal zone, pre-operative dissections and subclavian bypasses prior to stent graft placement.Secondary interventions: stent graft migration, proximal type i endoleak, distal type i endoleak, type ii endoleak, aneurysmal evolution of the descending thoracic aorta, aneurysmal expansion of the dissected abdominal aorta in one patient ,retrograde dissection, rupture of the right external iliac artery, inaccurate delivery, intentional and unintentional coverage of the left common carotid artery, cva, pulmonary embolism, paralysis, renal issues, inaccurate delivery, occlusion, aneurysm enlargement, and death.Objective: this study assessed predictive factors for reintervention after thoracic endovascular aortic repair (tevar) for complicated aortic dissection (c-ad).Methods: an institutional review of consecutive tevar for c-ad was performed.Results: between 2000 and 2011, 41 patients underwent tevar for a c-ad involving the descending thoracic aorta.Primary indications included aneurysm >55mm in 24, rapid aneurysmal enlargement or impending rupture in 6, saccular aneurysm >20 mm in 1, malperfusion in 1, intractable chest pain in 3, and rupture in 6.Technical success was achieved in 100%.The 30-day mortality rate was 5% (n[2).Fourteen secondary procedures were performed in 13 patients (32%) for indications of device migration in 2, proximal type i endoleak in 5, distal type i endoleak in 2, type ii endoleak in 1, aneurysmal evolution of the descending thoracic aorta in 2, aneurysmal expansion of the dissected abdominal aorta in 1, and retrograde dissection in 1.Multivariate analysis demonstrated that oversizing (b)(4) (odds ratio [or], 16; p[.011), bare-spring stent in the proximal landing zone of the stent graft (or, 12; p [.032), and anticoagulant therapy (or, 78; p [.03) were significant factors for reintervention.On univariate analysis, large aneurysm was a risk factor for reintervention (p [.002), whereas complete false lumen thrombosis at the stent graft level was protective (p <(><<)>.05).Conclusions: this study confirms the feasibility of tevar for c-ad, although the rate of reintervention is high.Excessive oversizing, a bare-spring stent graft in the proximal landing zone, large aortic dilatation, and anticoagulant therapy were factors associated with reintervention.Complete false lumen thrombosis at the stent graft level was protective.(j vasc surg 2014;59:327-33.).

Manufacturer Narrative

(b)(4).Evaluation results: inherent risk of procedure (migration, endoleak, retrograde dissection, rupture of the right external iliac artery, inaccurate delivery, cva, pulmonary embolism, paralysis, renal issues, occlusion, aneurysm enlargement, and death).Patient¿s condition affected effectiveness of device (anatomy related: short proximal landing zone (<(><<)>20 mm), tortuous seal zone).(unknown cause of all events).Evaluation conclusion: device failure/lack of effectiveness related to patient condition (anatomy related: short proximal landing zone (<(><<)>20 mm), tortuous seal zone).(unknown cause of all events).Evaluation conclusion: device failure/lack of effectiveness related to patient condition (anatomy related: short proximal landing zone (<(><<)>20 mm), tortuous seal zone).(unknown cause of all events).(b)(4).

• 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: 3645010
• MDR Text Key: 4184709
• Report Number: 2953200-2014-00330
• 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,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: 02/25/2014
• 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; Required Intervention
• Patient Age: 00066 YR