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

Model Number MI2355A

Device Problem Use of Device Problem (1670)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 06/30/2022

Event Type  Injury  

Event Description

It was reported that, during the implant procedure of a leadless implantable pulse generator (ipg), after the leadless ipg delivery system (ds) tether was cut, the patient experienced a drop in blood pressure, cardiac perforation, resultant cardiac tamponade, confirmed on echocardiogram and cardiac arrest, with resuscitation for 10 minutes.Initially, there was difficulty in inserting the dilator into the leadless implantable pulse generator (ipg) sheath, therefore, the introducer sheath was attempted/not used and replaced with a larger sized sheath.Post first implant attempt, the leadless implantable pulse generator (ipg) dislodged during the pull and hold test.Before the first successful implant, a computerized tomography (ct) confirmed that the leadless ipg and its ds were near the lower cardiac wall, and it was deemed possible that the heart was perforated at this time, possibly relating to positioning/placement.It was immediately after the first successful implantation and cutting the leadless ipg ds tether, that the patient became unstable.After the patient's condition stabilized, post cardiac arrest, a thoracotomy was performed.It was discovered that duringthe thoracotomy that the leadless ipg damaged tine at 9 o'clock, had potentially perforated the heart, where the metal part on the free wall side was visible after thoracotomy.Hemorrhaging was visualized, but it could not be confirmed with other devices, so the procedure was completed.Post treatment, the patient's condition stabilized.The leadless ipg remains in use.Medical intervention was required as a result of this event.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.

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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15092675
• MDR Text Key: 296468137
• Report Number: 9612164-2022-02799
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: 00166179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 08/31/2022
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 42 KG