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

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

Patient Problems Neurological Deficit/Dysfunction (1982); Paresis (1998); Coma (2417); Multiple Organ Failure (3261)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; retrograde type a dissection after thoracic endovascular aortic repair: surgical strategy and literature review zhao an, md, zhigang song, md, hao tang, md, lin han, md, zhiyun xu, md department of cardiovascular surgery, changhai hospital, second military medical university, shanghai, china http://dx.Doi.Org/10.1016/j.Hlc.2017.03.168.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant stent graft system was implanted in the patient for the endovascular treatment of thoracic aneurysm repair.The following adverse events were observed; type a dissection, chest pain, paraparesis, multi-organ failure, coma, neurological dysfunction.

• Brand Name: VALIANT 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: 7494010
• MDR Text Key: 107580099
• Report Number: 2953200-2018-00661
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2018

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: 04/16/2018
• Initial Date FDA Received: 05/08/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 49 YR