MAUDE Adverse Event Report: MEDTRONIC CRM UNIT MEDTRONIC; VALVE AORTIC T21: 21603100

Model Number 305C221

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2013

Event Type  Other  

Event Description

The blue cinch device was inadvertently left in the valve.There was no way to identify it on x-ray suggest making device with a radiopaque substance which could be discovered on x-ray.This retained valve cinch did not cause the pt's death but did lead to a secondary shunt procedure 3 months later.The pt died over 2 years later of other co-morbid issues.The retained valve cinch was discovered on autopsy.

• Brand Name: MEDTRONIC
• Type of Device: VALVE AORTIC T21: 21603100
• Manufacturer (Section D): MEDTRONIC CRM UNIT; moundsview MN
• MDR Report Key: 5535731
• MDR Text Key: 41549870
• Report Number: 5535731
• Device Sequence Number: 0
• Product Code: LWR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: 305C221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/09/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR