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

Model Number MI2355A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/24/2022

Event Type  Death  

Event Description

It was reported that intra-operative the patient experienced cardiac perforation of the right ventricular (rv) and left ventricular (lv), and possibly the interventricular septum during an attempt to implant a leadless implantable pulse generator (ipg) system.It was also reported that the patient experienced tamponade and effusion.  one deployment was attempted in the mid septal location. it was reported that the leadless ipg exhibited no capture and relocation was attempted. cardiopulmonary resuscitation was performed.Sternotomy was performed.Two visible perforations were noted. visible tears were surgically repaired on either side of left anterior descending artery on the rv and the lv.The leadless ipg system was attempted/not used and was removed. an epicardial ipg system was implanted approximately two days later.It was reported that the patient's pressure dropped and the patient expired due to complications arising from the leadless ipg procedure approximately five days post the procedure.

Manufacturer Narrative

Product event summary: the introducer was returned, analyzed, and no anomalies were found.The delivery system introducer sheath was kinked/buckled.Visual analysis of the introducer indicated damage during use.The analyst noted the introducer was returned with the dilator inserted into the sheath.The sheath was kink/buckled at 17.5 cm.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: 14743083
• MDR Text Key: 294376029
• Report Number: 9612164-2022-02320
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00643169359888
• UDI-Public: 00643169359888
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: 00152849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/04/2020
• 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): Death
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 47 KG