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

Model Number MI2355A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Thrombosis (2100); Thrombus (2101)

Event Date 04/02/2015

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 deep vein thrombosis that was nearly occlusive in the right common femoral vein extending into the right external iliac vein.The thrombus was diagnosed after a failed attempt at a placement of a leadless implantable pulse generator (ipg) via the right femoral vein with tortuous vein anatomy.It was suspected to have been caused by the introducer at the implant attempt.The patient was medicinally treated and hospitalized.A inferior vena cava (ivc) filter was also placed.The patient is a participant in the post approval network (pan) product surveillance registry (psr).No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: this rr is a duplicate of regulatory report 9612164-2015-00954.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8382441
• MDR Text Key: 137549916
• Report Number: 9612164-2019-00747
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00643169359888
• UDI-Public: 00643169359888
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2016
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: 00099123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2019
• Date Device Manufactured: 09/18/2014
• 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
• Patient Age: 88 YR
• Patient Weight: 64