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

Model Number MI2355A

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

Patient Problems Bradycardia (1751); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 06/30/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that, approximately two hours post leadless implantable pulse generator (ipg) implant procedure, the patient died.It was reported that, prior to the implant procedure, the area for deployment of the leadless ipg delivery system (delsys) was confirmed by contrast enhanced computerized tomography (ct).Then, on the first deployment attempt, the device slipped when pressure was applied to the tip, without deployment.Subsequently, the area for deployment was changed.After the process above was repeated three times, and on the fourth deployment, the tines were checked and the two tines on the septal side were stuck, but subsequently, confirmed to be connected and the leadless ipg was implanted.At this point the patient developed bradycardia.A pericardial effusion was confirmed, evolving into cardiac tamponade and the patient was opened up for a thoracotomy.Percutaneous cardiopulmonary support (pcps) was initiated and cardiac massage was performed, but the condition was not deemed stable.There were two cardiac perforation points discovered when performing the thoracotomy: one was near where the leadless ipg was implanted and was deemed to be caused by the leadless ipg implant procedure, and the other was in the upper part of the heart, which was considered to be damage caused by the cardiac massage.The perforation near the leadless ipg implant site was sutured, but the other perforation could not be sutured because the myocardium was too fragile, and the heart was covered with fibrin and the incision was closed.The patient was treated in the intensive care unit (icu), for two hours before their death.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 ; EI
• MDR Report Key: 12293883
• MDR Text Key: 265586158
• Report Number: 9612164-2021-03056
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K132030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• 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
• Device Lot Number: 00154772
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 30