MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVOLUTR-34

Device Problems Material Deformation (2976); Activation Failure (3270); Patient Device Interaction Problem (4001)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Cardiac Output (2501); Cardiovascular Insufficiency (4445)

Event Date 09/26/2023

Event Type  Injury  

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.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the patient had a bicuspid valve with moderate calcification in the region of the aortic ring.Pre-implant balloon aortic valvuloplasty (bav) was performed with a 25x40 balloon.The valve was introduced but failed to expand fully ¿ it had an elliptical shape.The valve¿s hemodynamics were not good at this time, the patient¿s gradient was around 59 mmhg.The valve was reassembled and released two more times, leaving it with the same elliptical shape.The physician decided to remove the valve and delivery catheter system (dcs) and to pre-dilate with a 28x40 balloon.Once removed from the patient, the valve was checked and found intact without any folds or infolds.The dcs was exchanged as it showed signs of wear due to the three recaptures.A new dcs was introduced with the valve, however the valve had the same elliptical shape due to severe calcification.The physicians attempted implantation two more times unsuccessfully, and so the implant was aborted.The valve and dcs were removed from the patient, and once again checked for defects but were found intact with no dents or other damage.The physicians stated that the patient¿s anatomy did not favor opening the valve due to the amount of calcification.No additional adverse patient effects were reported.

Manufacturer Narrative

Image review: intraprocedural fluoroscopic images were submitted to medtronic for review of the event.The patient¿s executive summary was provided for anatomical review.The patient¿s annulus perimeter measured 87.8 millimeter (mm) with a perimeter derived diameter of 27.9 mm suggesting a 34mm evolut.Additionally, the aortic valve appeared to be a possible bicuspid with a fusion between the right and non-coronary cusps and significantly calcified.Fluoroscopic valve load inspection of the first valve was provided for review and confirmed a good load.A pre-implant balloon aortic valvuloplasty (bav) was performed prior to valve implant.There was no evidence of infold with the first deployment attempt but was very deep which warranted a recapture.An infold is noticeable after the second deployment attempt.The infold is characterized by an inward fold or crease in the valve, extending from the inflow.Infolding could occur due a misloaded valve, anatomical characteristics such as calcium, and recaptures.According to medtronic best practices, if an infold is identified, the valve should be recaptured, removed from the body, and discarded.New sterile components must be used.It was reported that the same valve was reused and reloaded into a new catheter.Of note, the instructions for use (ifu) states ¿if a bioprosthesis and catheter have been removed from a patient, dispose of both the bioprosthesis and catheter; do not attempt to reuse either component.Both the bioprosthesis and catheter must be replaced with new sterile components.¿ another pre-implant balloon aortic valvuloplasty was performed.During the implant attempt, the valve appeared to be significantly under expanded.The valve was not released at this time, and another balloon aortic valvuloplasty was performed.Succeeding implant attempts resulted in significant under expansion and infold.Subsequently, further attempts at implantation were aborted.Updated: b1, 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

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 indicating that with the first system, at 80% deployment, the patient experienced hypotension and low cardiac output.It was reported that the patient¿s anatomy did not allow for complete expansion of the valve, preventing the opening and closing of its leaflets, which altered the patient¿s hemodynamics.It was reported that the high gradient was a result of the elliptical shape of the valve.Prior to the valve implant, the patient¿s gradient was 65 millimeters of mercury (mm hg).It was reported that the same valve was used with the first and second delivery catheter system (dcs).Per the physician, the patient was in stable condition following the procedure.It was noted that the patient had a possible bicuspid native aortic valve with fused right coronary cusp (rcc) and non-coronary cusp (ncc).Protruding annular calcium was observed under the rcc and lcc, extending into the left ventricular outflow tract (lvot).

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• 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: 17988135
• MDR Text Key: 326307812
• Report Number: 2025587-2023-04286
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-34
• Device Catalogue Number: EVOLUTR-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/09/2023; 12/08/2023
• Supplement Dates FDA Received: 11/15/2023; 12/15/2023
• Date Device Manufactured: 06/11/2023
• 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): Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male