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

Model Number D-EVPROP2329US

Device Problems Failure to Advance (2524); Material Protrusion/Extrusion (2979)

Patient Problems Stroke/CVA (1770); Visual Impairment (2138)

Event Date 08/02/2022

Event Type  Injury  

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 using this delivery catheter system (dcs), difficulty was reported in crossing the native aortic valve.A porcelain aorta was reported.The dcs was unable to advance past the sinotubular junction and was withdrawn to the descending aorta.A second attempt to cross was made but was not successful.The dcs was completely withdrawn from the patient and a piece of calcium was embedded in the proximal portion of the capsule, creating a bulge.The valve was removed and rinsed.The valve was re-loaded onto a replacement dcs by an experienced medtronic field representative loader.An attempt was made to cross the aortic valve again using a snare technique to center the dcs in the ascending aorta.The replacement dcs was not able to cross the native annulus.A stroke was reported with right peripheral vision loss and word finding difficulty.The dcs was withdrawn and the valve implant was aborted.A computed tomography (ct) scan confirmed a stroke.The patient was discharged to a rehabilitation facility.Per the physician, the cause of the stroke was unknown.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the handle was intact.The subject delivery catheter system (dcs) was received with the capsule partially opened.The deployment knob retracted and advanced the capsule.The trigger moved to fully advance and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.The device was returned with the end cap/screw gear snap fit connected.The capsule tip had a bulge with two separate points of nitinol protrusion.Delamination was observed over the nitinol reinforcing frame along the proximal end of the capsule.The proximal end of the inner member shaft was kinked.Conclusion: the subject dcs was returned to medtronic for analysis.Procedural images were provided and an image review was completed.The capsule tip had a bulge with two separate points of nitinol protrusion.Nitinol protrusion may be caused by an unanticipated interaction between the capsule flare and a hard surface during loading or insertion (interaction with loading system or introducer sheath), which plastically deforms the nitinol crowns and causes them to protrude through the capsule polymer.In this case, it was noted in the event description that a piece of calcium was embedded in the proximal portion of the capsule, creating a bulge.Delamination was observed over the nitinol reinforcing frame along the proximal end of the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.The proximal end of the inner member shaft was kinked, however the description of the event does not indicate that this damage occurred during the reported issue.Inner member shaft kinks have historically been observed when the device was returned for analysis with the capsule open and no stylet in place to support the shaft, as was observed in this case.Procedural images were provided and an image review was completed.The image shows the presence of calcium in the ascending aorta.The dcs appears to be in the sinus of valsalva (sov) region, however it is not clear if this imaging shows the first or second dcs used in the procedure.Without further imaging, a reason for the reported unable to advance cannot be determined.The event description indicates that the dcs was unable to advance past the sinotubular junction.Difficulties advancing the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that the patient had a porcelain aorta and the images provided show calcium in the ascending aorta.This indicates that the probable cause of the advancement difficulties was patient anatomy.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.A stroke was reported with right peripheral vision loss and word finding difficulty.Stroke is a known potential adverse effect per device instructions for use (ifu).Per the physician, the cause of the stroke was unknown.With the limited information available, an assignable root cause could not be determined.A device history record (dhr) review was performed on the dcs and there were no correlations/ issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The dhr review did not show any findings related to this event.There is no information to suggest that a device malfunction or a failure to meet manufacturing specifications was related to these events.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 DCS
• 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: 15298627
• MDR Text Key: 298656374
• Report Number: 2025587-2022-02372
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• 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
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0011219574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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): Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 97 KG