MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA AV; LEADLESS PACEMAKER

Model Number MC1AVR1

Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2023

Event Type  malfunction  

Event Description

It was reported that during the implant procedure the leadless implantable pulse generator (ipg) was unable to be retrieved and deployed.The ipg was attempted/not used and replaced. no patient complications have been reported as a result of this event.

Manufacturer Narrative

This is a system report.The section d information is for the primary device, which was in use with the following: brand name micra product id mc1avr1 (serial: (b)(6).) section d references the main component of the system.Other medical products in use during the event include: 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

Product id: mc1avr1 product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Product id: mc1avr1-delsys product event summary: a partial delivery system was returned and analyzed.The lumen of the delivery system was torn.The inner boss of the delivery system was loose.The bond of the inner boss of the delivery system released from the inner shaft.The delivery system tether was broken/cut/pulled apart.Blood was observed in the lumen of the delivery system.The analyst noted a partial delivery system was returned with the device intact with the tether but not fully recaptured in the device cup and the tether pin was not returned.The deployment button was locked in the recaptured position on the delivery system handle upon receipt.The tether was cut at the tether tube of the delivery system and is not visible in the tether tube.The tether was cut too far back so that the device could not be recaptured in the device cup and the tether is within the lumen of the inner shaft.Articulation could not be performed as the tether was cut not allowing the device to be recaptured.The inner boss bond released from the inner shaft.The inner boss was loose on the inner shaft.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MICRA AV
• Type of Device: LEADLESS PACEMAKER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18128776
• MDR Text Key: 328007164
• Report Number: 9612164-2023-05178
• Device Sequence Number: 1
• Product Code: PNJ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P150033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2024
• Device Model Number: MC1AVR1
• Device Catalogue Number: MC1AVR1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 03/19/2025
• Supplement Dates FDA Received: 12/07/2023; 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• 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 Age: 77 YR
• Patient Sex: Male