MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; INTRODUCER, CATHETER

Model Number MI2355A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced cardiac perforation and tamponade during the implant attempt of the leadless implantable pulse generator (ipg) device.Fluoroscopy confirmed location, but post deployment fluoroscopy showed that the delivery system possibly moved prior to the deployment.It was decided to reposition the leadless device, but the patient became unresponsive and hypotensive.The implant was abandoned.The patient was taken to surgery; diagnosed with right atrial perforation presumably caused by introduction of the introducer and delivery system.No further patient complications have been reported as a result of this event.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7461831
• MDR Text Key: 106569025
• Report Number: 9612164-2018-00912
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2018
• 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: 84 YR
• Patient Weight: 89