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

Model Number MC1AVR1

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: d1: micra, d4: model #: mc1avr1-delsys,  serial#: (b)(6), d9: yes, return date: 19th mar 24, h3: no, device evaluation anticipated, but not yet begun, dev rtn to mfr? yes.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.

Event Description

It was reported that during implant of the leadless implantable pulse generator (ipg), the device was deployed multiple times with no good data.It was noted during recapture the tricuspid valve got damaged as the device got caught.It was further noted that the device could not be stored in the delivery system (ds) cup due to bent button and the tether broke when trying to remove the device.The device had to be removed using a snare.The leadless ipg and ds was attempted/not used and replaced.Tricuspid regurgitation had increased compared to before the surgery, and is not currently at a level that requires treatment, the patient will be monitored.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary for pli 20: the full delivery system was returned and analyzed.The lumen of the delivery system was torn.The delivery system tether was broken /cut/pulled apart.The delivery system tether was frayed.Blood was observed in the lumen of the delivery system.Blood was observed on the device cup of the delivery system.Blood was observed on the recapture cone of the delivery system.The analyst noted the full delivery system was returned with the device separated from the tether and delivery system.The tether was torn.There were no anomalies found with the distal edge of the device cup.Deflection and articulation could not be performed as the tether was torn and removed from the delivery system.There were no anomalies found with the deployment button.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.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.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: 18941710
• MDR Text Key: 338139760
• Report Number: 9612164-2024-01338
• Device Sequence Number: 1
• Product Code: PNJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC1AVR1
• Device Catalogue Number: MC1AVR1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2024
• 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): Other