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

Model Number MI2355A

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

Patient Problems Hematoma (1884); Thrombosis (2100); Thrombus (2101)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure of the leadless implantable pulse generator (ipg), a thrombus and hematoma occurred.The patient developed a deep vein thrombosis (dvt) which was attributed to a long procedure time.Anticoagulation medication was administered and subsequent doppler imaging evidenced resolution of the dvt.The hematoma was at the groin introducer site and did not require any medical intervention but resolved on its own.It was further reported that during the implant procedure, after placement of the ipg, the tether on the delivery system was cut and was unable to be removed.The delivery system could not be moved forward or backward despite several attempts and the delivery system was unable to retrieve the ipg.It was decided to remove the ipg and delivery system together.Upon removal, intracardiac tissue remnants were knotted up with the tether that were most likely part of tricuspid valve apparatus, part of chordae, and tissue of one of the leaflets.On subsequent echo evaluation, there was evidence of significant tricuspid regurgitation which did not have any significant clinical expressions on patient evaluation right after procedure or one month later and didn¿t require any surgical or medical intervention.A transvenous ipg system was implanted the following day.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,ie
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9205609
• MDR Text Key: 162999486
• Report Number: 9612164-2019-04409
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K132030
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• 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: 05/20/2019
• 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): Required Intervention