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

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Exemption number: e2015028.Total number of death events being summarized: 1.Date of death: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

This event is being reported as part of a bulk data release provided to medtronic from the society for vascular surgery - patient safety organization tevar dissection surveillance initiative.This data has been provided to medtronic by a third party (m2s) and is limited and de-identified.

Event Description

Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes
179240,,D,2014,Valiant,VAMC3232C150TU; VAMF3232C200TU,C76126

• Brand Name: VALIANT CAPTIVIA 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: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 7156330
• MDR Text Key: 96107406
• Report Number: 2953200-2017-02035
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 12/31/2017
• 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