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

Model Number	GWBC30
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rupture (2208); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	05/16/2022
Type of Reportable Event	Death
Event or Problem Description
Medtronic received information that during the implant of a transcatheter bioprosthetic valve, as the delivery catheter system (dcs) was being advanced, the guidewire caused a left ventricle rupture.Tamponade occurred as a result and drainage was performed.Subsequently, the patient died the same day.Per the physician the cause of death was the left ventricle laceration and tamponade caused by the guidewire.
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The guidewire was discarded.Without a return of the guidewire visual inspection of the guidewire for any user applied p re-shaping or damage that would have led to the perforation/rupture, laceration, tamponade and subsequent patient death could not be performed.Angiographic images were not available to analyze the procedure, the specific location and handling of the guidewire, and how the guidewire resulted in a perforation/rupture, laceration, tamponade and subsequent patient death.Per the warnings in the device 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 device 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 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 does not move forward and cause trauma to the left ventricle (lv).A review of the device history record for the guidewire found the device was built to specification and met all inspection and acceptance criteria.No issues were noted that would have impacted this event.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 lv perforation.The physician stated the patient death was the result of a left ventricle laceration/perforation and tamponade caused by the guidewire.Rupture/perforation, laceration, tamponade and patient death are 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 did not indicate a 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.

• Brand Name: CONFIDA BRECKER CURVE GUIDEWIRE
• Common Device Name: 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: 14496394
• Report Number: 2025587-2022-01474
• Device Sequence Number: 15000360
• Product Code: DQX
• UDI-Device Identifier: 00763000060886
• UDI-Public: 00763000060886
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K132623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 92006225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/21/2022
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Sex: Female
• Patient Weight: 53 KG