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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Pulmonary Embolism (1498); Cardiopulmonary Arrest (1765); Ischemia (1942); Paralysis (1997); Renal Failure (2041); Sepsis (2067); Reaction (2414)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Journal information: title: outcomes of planned two-stage hybrid aortic repair with dacron-replaced proximal landing zone authors:david n.Ranney, babatunde a.Yerokun, ehsan benrashid, muath bishawi, adam williams, richard l.Mccann and g.Chad hughes the society of thoracic surgeons, 2018;106:1136¿42, doi.Org/0.1016/j.Athoracsur.2018.04.044.If information is provided in the future, a supplemental report will be issued.

Event Description

Valiant and talent sent graft systems were implanted into 3 patients (out of a study group of 34 patients) for the second stage of thoracic aortic repair from january 2006 and august 2017.The first stage of treatment involved either hybrid arch repair (har) or total arch replacement (tar).It was reported that during that time the following adverse events were reported in the entire patient group: serious injury stroke pulmonary embolism allergic reaction cardio pulmonary disease sepsis retrograde type a dissection reintervention.

Manufacturer Narrative

Updated post investigation closure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TALENT TAA STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 8008377
• MDR Text Key: 125095294
• Report Number: 9612164-2018-02946
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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: 10/16/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 01/15/2019
• 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: 59 YR