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

Model Number GWBC30

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fistula (1862); Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152); Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 05/09/2023

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, a 22 french (fr) sheath was inserted and a pre-balloon aortic valvuloplasty (bav) was performed with a 22 millimeter (mm) non-medtronic balloon.The balloon "watermelon seeded" out and crushed the wire.A second pre-bav was performed with a 22 mm non-medtronic balloon and was successful.Subsequently, the valve was deployed in a favorable location.  at 80% deployment, the catheter was centered due to the steep aortic root angle (70 degrees).The valve was released and the patients pressures began to drop and cardiopulmonary resuscitation (cpr) was performed.An effusion was noted on a transthoracic echocardiogram (tte) and pericardiocentesis was performed.Blood was noted around the annulus and in the aorta.Chest compressions continued for 30 minutes and a decision was made to stop. the patient was declared deceased.Although the exact cause of death is unknown, the doctor suspects that an aortic dissection into the pericardium was the reason. of note, no extracorporeal membrane oxygenation (ecmo) or bypass was performed due to the patients comorbidities.

Manufacturer Narrative

Correction: d., g4.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.

Event Description

Additional information was received that transfemoral right access site was used for the delivery catheter system (dcs).It was noted to be possible that the "watermelon seeding" caused injury when it crushed the wire, but per the physician unlikely.The cause of the bleeding was relatively unknown.There was a possible annular fistula near the left coronary cusp that may have played a part.Interaction between the wires and chest compression also may have played a part in the bleeding.Per the physician, it was not likely that the dcs played any part in causing or contributing to the dissection.Of note, a perforation/laceration was noted on the echocardiogram at the non-coronary cusp at some point during or shortly after life saving treatments were performed.

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.

Manufacturer Narrative

The device was discarded; therefore, no product analysis can be performed.Updated data: g2.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.

Manufacturer Narrative

Conclusion: four media files were provided for review of the event.The patient¿s executive summary was provided for anatomical review.The patient¿s annulus perimeter was 94.4 millimeter (mm) with a perimeter derived diameter of 30.1mm which falls outside of the patient anatomical criteria in the device instructions for use (ifu).Additionally, the patient¿s aortic root angle was 70 degrees.A pre-implant balloon aortic valvuloplasty (bav) was performed in which the wire appeared slightly deep into the left ventricle.However, a better view would be required to confirm adequate wire position.The valve was deployed to 80% and valve position was assessed in the lao view.The valve appeared to be biased towards the outer curve of the aorta.Despite the information provided, the cause of the effusion that led to the patient¿s death remains unclear.Potential risks associated with the implantation of the evolut fx bioprosthesis may include, but are not limited to, the following: death, myocardial infarction, cardiac arrest, cardiogenic shock, cardiac tamponade, cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention).A medical safety assessment was performed.Upon review of the information provided, the primary event of suspected aortic dissection leading to pericardial effusion and pericardiocentesis and cardiopulmonary resuscitation (cpr) resulting in death is assessed as u nknown related to the fx valve, delivery catheter system (dcs) and confida guidewire.The physician noted multiple possibilities without conclusive evidence for the cause of bleeding leading to death.Possibilities included were; 1) watermelon seeding of the balloon during the first bav causing dissection when it crushed the guidewire 2) possible annular fistula on the left coronary cusp (lcc) and 3) guidewire and cpr interaction during live saving measures.Of note there was a perforation/laceration at the non-coronary cusp (ncc) shortly after cpr.The image review report notes that the cause of effusion that led to the patient¿s death remains unclear.Of note, the annulus perimeter (94.4mm) and perimeter derived diameter (30.1mm) were outside the recommendations of the ifu and the aortic root angle was 70 degrees.The adverse events reviewed in this medical safety assessment are known potential risks associated with the implantation of the fx valve and use of the confida guidwire.The reported harms and severities are documented in the risk files and ifu.No further safety assessment is required at this time.Vascular injuries such as perforation, effusion and, dissection are known potential adverse patient effect per the device ifu, and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).In this event, it is unknown whether resistance was felt during the positioning.Per the warnings in the confida ifu, the guidewire should not be pushed pulled or rotated against resistance, and the wire position should be monitored throughout the procedure for proper placement of the curve and distal tip.Hypotension is a known potential adverse effect per the device 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.Patient death is a potential risk associated with transcatheter aortic valve replacement (tavr) per the device ifu.A procedure- or device-related death can occur despite an ideal implant procedure or device functionality.The physician noted multiple possible causes of the events, including watermelon seeding of the balloon during the first bav causing dissection when it crushed the guidewire, possible annular fistula on the lcc, guidewire-cpr interaction during live saving measures.However, with the information available, none of these causes were able to be confirmed.Per the image review, the patient anatomy was outside the recommendations of the ifu and the aortic root angle was 70 degrees, which could serve as a potential contributing factor for the reported events.Without a returned guidewire for analysis, we are unable to inspect the guidewire for any user applied pre shaping or damage that could have led to a perforation, dissection, effusion and resulted in the patient death.This event does not indicate device misuse or 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
• 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: 16989918
• MDR Text Key: 315815664
• Report Number: 2025587-2023-02175
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2023

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 05/24/2023; 06/19/2023; 06/20/2023; 08/21/2023
• Supplement Dates FDA Received: 06/14/2023; 06/19/2023; 07/12/2023; 08/28/2023
• Date Device Manufactured: 03/14/2023
• 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): Death
• Patient Age: 84 YR
• Patient Sex: Male