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

Model Number EVPROPLUS-34US

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Stroke/CVA (1770); Speech Disorder (4415)

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: other relevant devices are: product id: evproplus-34us, serial#: (b)(4), ubd: 19-may-2022, udi#: (b)(4); product id: d-evprop34us, lot #: 0010670514, ubd: 06-may-2023, udi#: (b)(4) product analysis: the initial valve was not returned, the dcs was discarded, the second valve remains implanted, and no procedural images were submitted for review; therefore, no product analysis can be performed.Conclusion: without the 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.

Event Description

Medtronic received information that during the attempted implant of this transcatheter bioprosthetic valve, in a patient with significant calcification in the aortic annulus and a dilated and calcified aortic root, the valve was partially deployed, but the implant position was too deep.The valve was recaptured.During the second deployment attempt, an infold was noted in the valve fame.The valve was withdrawn from the patient and not implanted.A new valve was implanted.Following the valve implant, the patient presented with stroke symptoms and was not able to speak.A computed tomography showed multiple emboli in the cerebral vessels.Per the physician, the stroke was a result of calcific emboli from the aortic annulus during recapture of the initial valve.One day following the valve implant, the patient's symptoms improved and speech returned.No treatment was reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the reported event indicates that the valve was recaptured once as the implant position was too deep.Recapturing is a feature of the evolut system that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.In this case, it was noted that there was significant calcification in the aortic annulus and a dilated and calcified aortic root.This indicates that the probable cause of the positioning difficulties was patient anatomy, but this cannot be confirmed with the information available.There is no information to suggest a device quality deficiency that may have caused or contributed to this event, but the cause of the positioning difficulty could not be conclusively determined with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.During the second deployment attempt, an infold was noted in the valve fame.The valve was withdrawn from the patient and not implanted.A new valve was implanted.Updated data: results and conclusion codes 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

Upon further review, the device relatedness of this previously reported event was updated.Per the physician, the stroke was a result of calcific emboli from the aortic annulus during the recaptures performed with the first valve.There is no evidence to suggest the second valve, initially reported as a concomitant product, caused or contributed to the serious injury.This report is filed to remove the concomitant product from the report.Corrected data: d10.Concomitant prod.Is no 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

Product analysis: the device was received via fedex in original packaging and container jar, submerged in clear solution.The valve was discolored showing evidence of blood contact.The outflow aspect exhibited an oval-shaped appearance.The inflow was distorted with a kidney-shaped likely associated with the reported infold.All leaflets were flexible and intact.All leaflets presented signs of creasing; conditions attributed to the valve being in the crimped position for an unknown amount of time.All leaflets were twisted and partially closed.All commissures were intact.The valve was submerged in warm saline to reset the frame.The valve was submerged in cold saline to perform loading simulation.Upon loading, both frame paddles appeared seated within the paddle attachment pockets.The capsule was advanced covering the frame paddles and outflow crown struts.The capsule was advanced until the capsule guide tube covered the commissure pad of the valve.The inflow cone was advanced to crimp the inflow portion of the valve.The capsule was fully advanced over the valve; no anomalies were identified.The valve was deployed in a warm saline bath by rotating the deployment knob exposing the valve.The valve was deployed up to the point of no recapture; no issues were observed.At this point, the valve was fully deployed and appeared to exhibit complete dilation; no anomalies were noted.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Infolding events are typically related to patient anatomical factors (i.E., calcification level, lvot anomalies, compliance of the annulus, bicuspid valve, etc.) and/or procedural factors (i.E., pre-case planning, sizing, loading, user technique, etc.).Additionally, the valve frame is constructed with nitinol and the latticed strut design allows the valve to be compressed and loaded into the delivery system.During either the loading or deploying/recapturing process, the struts may cross over and catch on each other while being compressed, and potentially cause infolding.Product analysis of the returned valve did not note any anomalies with valve loading and deployment.With the limited information available, a root cause for the infolding could not be conclusively determined but the significant calcium in the aortic annulus and a calcified aortic root were likely contributing causes.Stroke is a known potential adverse effect per the device instructions for use (ifu), with a variety of factors that can influence its onset.Per the physician, the stroke was a result of calcific emboli from the aortic annulus during the valve recapture.Due to the limited information available, this could not be confirmed by medtronic and a conclusive root cause of this event could not be determined.No treatment was reported for the stroke but one day following the valve implant, the patient's symptoms improved and speech returned.There is no information to suggest a device quality deficiency that may have caused or contributed to this.Updated data: d9 - device available for evaluation and return date h6 - method, results and conclusion codes.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.

• Brand Name: EVOLUT PRO PLUS 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12658034
• MDR Text Key: 277183291
• Report Number: 2025587-2021-03098
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000211158
• UDI-Public: 00763000211158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: EVPROPLUS-34US
• Device Catalogue Number: EVPROPLUS-34US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2025587-12/02/2022-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 68 YR
• Patient Sex: Male