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

Model Number MI2355A

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/25/2021

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, the patient experienced decreased blood pressure, decreased levels of consciousness, cardiac perforation, pericardial effusion and cardiac tamponade.On insertion of the leadless implantable pulse generator (ipg) delivery system (delsys), the physician considered that the delsys may have rubbed the upper edge, when passing through the tricuspid valve.Also, the position in the right atrium when pulling the introducer sheath to start the catheter operation was a little high.Post successful fixation of two tines of the leadless ipg, the patient became symptomatic and pericardial effusion was confirmed on echocardiogram.Pericardial drainage was commenced and the patient's blood pressure and remaining vitals stabilized.The patient was transferred to the intensive care unit (icu) and had a blood transfusion.The following day pacing failure was confirmed at high output.Dislodgement was suspected and the leadless ipg was explanted by snare and replaced with a trans-venous ipg system.On inspection of the leadless ipg, post explant, there was tissue and thrombus adhered to the tip, with possibility of electrode contact failure.No further patient complications have been reported as a result of this event.

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.

Event Description

It was further reported that the introducer sheath did not contribute to the cardiac perforation.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• MDR Report Key: 12425599
• MDR Text Key: 270491896
• Report Number: 9612164-2021-03424
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 93 YR
• Patient Weight: 51