MAUDE Adverse Event Report: MEDTRONIC, INC. MICRA; INTRODUCER, CATHETER

Model Number MI2355A

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

Patient Problems Fistula (1862); Thrombus (2101); Cardiac Tamponade (2226); Aortic Dissection (2491); Pseudoaneurysm (2605); Pericardial Effusion (3271)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age characteristics is male/77 years old.Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿acute and long-term outcomes of simultaneous atrioventricular node ablation and leadless pacemaker implantation.¿ pacing clin electrophysiol.2018; 41: 1484¿1490.Doi: 10.1111/pace.13496.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complications during the introducer sheath used for femoral access for the implantation of a leadless pacemaker and/or the use of a radio frequency ablation catheter: there was one (1) patient who experienced cardiac tamponade which required pericardial drainage.There was also one (1) patient with a ¿moderate¿ pericardial effusion, which resolved with conservative management and did not add any extra hospitalization.In one (1) patient the ¿left femoral vein was used to implant the device because the right femoral vein showed excessive tortuosity and a local dissection.The patient was discharged 24 hours after the procedure, with no short- or long-term complications within the follow-up period.¿ there were three (3) patients with an arteriovenous fistula; with no treatment/resolution indicated.There were also two (2) patients with arteriovenous pseudoaneurysms; with no indication of treatment/resolution.There was one (1) patient with a venous thrombosis, with no indication of treatment/resolution.Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method.The status/location of the sheath is unknown.Further follow up did not yet yield any additional information.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.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8275961
• MDR Text Key: 134036834
• Report Number: 2182208-2019-00163
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 77 YR