MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number GWBC30

Device Problem Positioning Problem (3009)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/29/2022

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the quidewire was placed in the left ventricle with a pigtail catheter.A pre-implant balloon aortic valvuloplasty (bav) was performed with a non-medtronic balloon.E xcessive force was used on the wire to get the balloon to the annulus.The balloon was inflated and removed from the patient.The transcatheter valve was inserted into the patient.During deployment of the valve, hypotension occurred.The valve was fully deployed.Cardiac effusion was observed and required cardiopulmonary resuscitation (cpr).It was noted that the guidewire perforated the left ventricle and pericardium.The patient was placed on extracorporeal membrane oxygenation (ecmo) and intubated and had open heart surgery to repair the perforation in the left ventricle.The patient was taken off ecmo and was closed successfully.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the device was discarded, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.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.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

Additional information was received that the guidewire was inspected prior to use and there was no damage.It was reported that there was tortuosity in the abdominal aorta and the balloon aortic valvuloplasty (bav) balloon did not track easily and required a lot of ¿pushing¿, as well as monitoring as it tracking through the abdominal aorta up into the annulus.This required the loss of constant tip visualization of the guidewire.Per the physician, the excessive pushing without constant monitoring on the guidewire while trying to get the bav annulus to the annulus caused the perforation and effusion.Hypotension occurred from the initial crossing of the aortic valve with the delivery catheter system (dcs), in addition to when the guidewire was removed from the apex of the left ventricle for valve deployment.It was believed that the guidewire was acting as a plug, keeping blood from exiting the left ventricle and when the guidewire was pulled back, there was no longer a ¿plug¿ in place to keep the blood from exiting the left ventricle.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

Conclusion: per the warnings in the confida guidewire instructions for use (ifu), the guidewire should not be pushed, pulled or rotated against resistance.If resistance is met, the ifu instructs to discontinue movement of the wire and determine the reason for resistance and take appropriate actions.In addition, the ifu cautions that the guidewire position should be monitored for proper placement of the curve and distal tip, and when crossing the aortic arch, the medtronic evolut valve ifu instructs that it is critical that the guidewire is controlled to prevent it from moving forward, so that the distal tip of the guidewire doesn't move forward and cause trauma to the left ventricle.The event description does not indicate a potential manufacturing issue with the confida brecker guidewire.In this event, the user stated that there was excessive force applied on the wire to get the balloon to the annulus, and required a lot of "pushing".This required the loss of constant tip visualization of the guidewire.Per the physician, the excessive pushing without constant monitoring on the guidewire while trying to get the balloon aortic valvuloplasty (bav) to the annulus led to the perforation, with secondary harms of hypotension and effusion.The confida ifu cautions the user to not manipulate the device without fluoroscopic visualization.In addition, cardiac perforation is known potential patient adverse effect per the ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.This event does not indicate device manufacturing related malfunction.Without the lot number, a lot history review is unable to be performed.The confida brecker guidewire consists of a pre-formed shape of the flexible distal tip which is specifically designed to position the guidewire in the left ventricle and mitigate the variability associated with the distal tip of regular guidewires.It also eliminates the need for physicians to manually bend the guidewire during the transcatheter aortic valve replacement (tavr) procedure, or other diagnostic and interventional catheterization procedures.In terms of tavr procedures, this pre-formed shape of the flexible distal tip is designed to provide stability for a tavr delivery system tracked over the guidewire and to mitigate the risk of left ventricle perforation.The medical safety assessment confirmed this event was due to the user applying excessive force on the guidewire.This event does not indicate device misuse or malfunction.Updated: h6 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: CONFIDA BRECKER CURVE GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15965069
• MDR Text Key: 305334430
• Report Number: 2025587-2022-03509
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 12/12/2022; 03/20/2023
• Supplement Dates FDA Received: 01/06/2023; 03/21/2023
• 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): Required Intervention; Life Threatening
• Patient Age: 91 YR
• Patient Sex: Female