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

Model Number D-EVOLUTFX-34

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id evproplus-34us ; serial number(b)(6); product type: 0195-heart valves; implant date n/a; explant date n/a product id evproplus-34us ; serial number(b)(6); product type: 0195-heart valves; implant date (b)(6) 2023; explant date n/a product id d-evprop34us; product lot 0011769939 ; product type: 0195-heart valves; implant date n/a; explant date n/a product id l-evprop34us; product lot unknown ; product type: 0195-heart valves; implant date n/a; explant date n/a product analysis: the device was not returned, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.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 prior to the implant of this transcatheter bioprosthetic valve, the valve was prepped and loaded onto the delivery catheter system (dcs) and inserted into the right common femoral artery using an in-line sheath.The dcs was advanced to the common iliac artery and subsequently met resistance.The dcs was rotated and attempted to advance further, but resistance was met again.The dcs was withdrawn from the patient.Dilation was performed to the iliac artery with non-medtronic dilators.A 22 french non-medtronic external sheath was inserted.Upon removal of the dcs, the inflow of the valve had protruded through the capsule.A new valve was prepped and loaded onto a new dcs.The dcs was advanced, and the valve was implanted in the aortic position successfully.No adverse patient effects were reported.

Manufacturer Narrative

Updated data: b5.G2.H6.Additional codes: annex f 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 the minimum diameter of the common iliac artery access vessel measured 7.5mm.It was noted the capsule flare was damaged when the inflow portion of the transcatheter aortic valve poked through.Difficulty inserting the delivery catheter system was noted.Subsequently, after the inline sheath of the first system was removed, a new system was prepped and delivered through an external introducer sheath.The patient¿s calcium and tortuous anatomy contributed to the valve protrusion.A procedural delay was observed.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with a valve loaded within the capsule.The device was received with the capsule partially opened.Delamination was observed over the nitinol reinforcing frame along the proximal end of the capsule.Four nitinol crowns were observed protruding through the polymer material at the distal end of the capsule.There was a slight bend to the stability shaft.The handle was intact.The device was returned with the end cap/screw gear snap fit connected.On retraction of the capsule via the rotation of the deployment knob, the valve deployed with a slight crown overlap.The valve crowns were not protruding through the capsule.The deployment knob retracted and advanced the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.Updated 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

Updated data: h6 - result and conclusion codes conclusion: procedural images were not provided for review.A number of factors may cause or contribute to the metal from the capsule flair beginning to protrude, including use condition (tortuous anatomical pathway and complex disease state), user technique (application of force and advancement technique), thickness of polymer covering the nitinol crowns (thin polymer wall), or an unanticipated interaction between the capsule flare and a hard surface during loading or insertion (interaction with loading system or introducer sheath).There was a slight bend to the stability shaft.It is possible that this occurred while preparing the device for return to medtronic or during transportation back to medtronic, however, this cannot be conclusively confirmed.There was no other damage noted to the remainder of the device.The reported event indicates that difficulty inserting the delivery catheter system was noted.The delivery catheter system (dcs) was advanced to the common iliac artery and subsequently met resistance.The dcs was rotated and attempted to advance further, but resistance was met again.Difficulties inserting and 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 there was calcification and the patient had tortuous anatomy.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Although it was reported that the inflow of the valve had protruded through the capsule, analysis of the device confirmed that the valve crowns were not protruding through the capsule, however, nitinol crowns were observed protruding through the polymer material at the distal end of the capsule.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications.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 FX 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: 17642519
• MDR Text Key: 323042746
• Report Number: 2025587-2023-03557
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: 00763000365684
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0011769938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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
• Treatment: SEE H10...
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 88 KG