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

Model Number GWBC30

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Encephalopathy (1833); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Unspecified Infection (1930); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Cardiac Perforation (2513); Cognitive Changes (2551)

Event Date 05/02/2022

Event Type  Death  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, as the guidewire was inserted into the left ventricle, a left ventricular perforation occurred.This was discovered at the time of the pre-balloon aortic valvuloplasty (bav) balloon delivery.The perforation resulted in tamponade and shock.Percutaneous cardio pulmonary support (pcps) was inserted and the upper perforation site of the thoracotomy was repaired.After hemostasis was achieved, the valve was then implanted and pcps was withdrawn.Impaired consciousness due to hypoxic encephalopathy occurred which did not resolve.Subsequently, one month and twenty-eight days later the patient died.

Manufacturer Narrative

Additional information was received which indicated that the guidewire was not manipulated prior to use.The guidewire was placed using a pigtail.There was report by the physician that the access route was ¿not good¿ and it was difficult to operate the wires.However, it was unknown if this was the cause of the perforation.Other patient factors were not reported.As confirmed, the perforation did not occur when the valve was being placed, rather before valve placement.No additional adverse patient effects were reported.Corrected data: h6 method code 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

Additional information was received which reported that the implanting physician thought the guidewire was placed into the left ventricle, however when the patient's blood pressure dropped, the physician realized that a perforation had occurred.The guidewire was manipulated under fluoroscopy.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

Updated data: b5.Additional information was received that access was achieved via transfemoral approach.The patient's descending aorta was bent and deflection occurred in the guidewire and the catheter which made advancement more difficult than usual.The perforation was noted prior to the pre-implant bav.No adverse patient effects were reported.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.

Manufacturer Narrative

Conclusion: in this event, the most likely cause was due to a use related event, combined with anatomy issues, that led to the perforation and subsequent secondary harms.Unfortunately, without the return of this guidewire for analysis, or the lot number of this guidewire, we are unable to review the lot history records and unable to perform a complete analysis.And without angiographic images of the guidewire usage we are unable to confirm the chain of events.The event description stated that the access route was "not good" and it was difficult to operate the wire.It is unknown if the report of the patients descending aorta being bent may have played a role in the perforation due to deflection of the guidewire.Per the tips and techniques for guidewire management, "consider use of a stiffer guidewire in horizontal aortas to assist in achieving a more coaxial and symmetric deployment".It was also stated that as the guidewire was inserted into the left ventricle a left perforation occurred, and this was discovered at the time of the pre balloon aortic valvuloplasty.The instructions for use (ifu) and product training materials also provide the following: that the guidewire transition point should be positioned above the apex, with the wire tip pointed away from the ventricle wall, while maintaining strict fluoroscopic surveillance of the guidewire at all times.Per the warnings in the confida ifu, the guidewire should not be pushed pulled or rotated against resistance, and the wire should position should be monitored throughout the procedure for proper placement of the curve and distal tip.The confida ifu, cautions the user to not manipulate the device without fluoroscopic visualization, and also cautions that without proper management of the distal tip of the guidewire, the guidewire could move forward and cause trauma to the left ventricle.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 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 lv perforation.In addition, cardiac perforation, death, tamponade, hypotension (hypovolemia), are known potential patient adverse effect per the ifu with resulting secondary harm of shock.Perforation is an effect that is highly dependent on the patient's pre-procedural condition and use conditions and can occur despite a normally-functioning device or model implant procedure.This event does not indicate device manufacturing related malfunction.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

Updated data: b5.H6.Additional codes: annex g.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.

Event Description

Additional information was received that the patient¿s consciousness did not recover due to hypoxic encephalopathy due to hypotension and eventually died of an infection.The cause of death was infection.Per the physician, the valve implant procedure was a contributing factor to the patient's death.

• 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: 15426848
• MDR Text Key: 299939533
• Report Number: 2025587-2022-02478
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132623
• 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,Followup,Followup,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• 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): Hospitalization; Required Intervention; Life Threatening; Death