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

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

Patient Problems Hemorrhage/Bleeding (1888); Occlusion (1984)

Event Date 01/01/2013

Event Type  Injury  

Event Description

The following information was obtained from a journal article.Endovascular repair of traumatic aortic injury: a novel arena in interventional cardiology patel, jigar; wayangankar, siddharth; zacharias, soni; stowell, donald; saucedo, jorge journal of interventional cardiology vol.26, no.1 doi: 10.1111/j.1540-8183.2012.00761.X the following adverse events were observed: endoleak, stent infolding no further information is available for this event.Objective: to assess the feasibility of endovascular repair of traumatic aortic injuries performed by interventional cardiologists in collaboration with cardiothoracic surgeons.Background: traumatic aortic injury (tai) represents a significant cause of mortality in trauma patients.Endovascular techniques have recently come into play for the management of tai and are usually performed by a multidisciplinary team consisting of a thoracic or vascular surgeon and/or interventional radiology.With extensive expertise in cat heter-based interventions, interventional cardiologists may have a pivotal role in this important procedure.Methods: from january 2009 to july 2011, we reviewed the tai endovascular repair outcomes performed by a team of interventional cardiologists in collaboration with cardiothoracic surgery at our institution.The charts of these patients were reviewed to collect desired data, which included preoperative, procedural, and follow-up details.Results: twenty patients were identified in our series.Most of these patients developed tai from motor vehicle accidents.Technical success for endovascular repair of tai was achieved in all patients.Two patients developed endoleak, of which one patient required subsequent open repair.Two patients expired in the hospital from coexistent injuries.Conclusion: our series of endovascular repair for tai performed by interventional cardiologists with the collaboration of cardiothoracic surgeons showed excellent outcomes.Our experience may give further insight in the collaborative role of interventional cardiology and cardiothoracic surgery for endovascular repair of tai.

Manufacturer Narrative

(b)(4): evaluation, results: inherent risk of procedure (endoleak, occlusion).Patient¿s condition affected effectiveness of device (blunt force trauma).Unapproved use of device (blunt force trauma).Conclusions: device failure related to patient condition (blunt force trauma).Known inherent risk of a procedure (endoleak, occlusion).(b)(4).

• Brand Name: TALENT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA
• 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: 3627110
• MDR Text Key: 4183232
• Report Number: 2953200-2014-00265
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: Yes
• 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: 02/13/2014
• 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: 00028 YR