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

Model Number D-EVOLUTFX-2329

Device Problems Failure to Advance (2524); Patient Device Interaction Problem (4001)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/27/2023

Event Type  Injury  

Event Description

Medtronic received information that during the attempted implant of this transcatheter bioprosthetic valve into a patient with peripheral artery occlusive disease, initial attempts to advance the sheath were unsuccessful.The common iliac and external iliac arteries were dilated using an 8mm balloon, which enabled the successful advancement of the sheath.The patient¿s annulus was subsequently dilated using a 22mm non-medtronic (vacs) balloon.However, the delivery catheter system (dcs) was still not able to advance.Bleeding in the iliac arteries was observed.Two 8mm covered stents were placed, which resolved the bleeding.However, due to extensive calcification and narrow vessel diameters, valve implantation was not possible.The procedure was subsequently aborted.No additional adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10: product id evolutfx-29 (serial: (b)(6); product type: 0195-heart valves; implant date.; explant date.Product analysis: no product was returned.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.

Manufacturer Narrative

Updated: b5.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 the right side was used as the access site and the injury occurred on the right side.The minimum diameter of the access vessel was 4.5-5 millimeter (mm).It was unknown when the injury occurred.Per the physician, the cause of the injury was dilatation of the iliac arteries.Per the physician, the delivery catheter system (dcs) did not cause or contribute to the injury.

Manufacturer Narrative

Updated data: d9: device available for evaluation and return date.H3: device evaluated, device returned to manufacturer and eval summary.H6: device, method, result and conclusion codes 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 fully closed.There was a bump visible on the capsule tip.There were scratches to the proximal and distal ends of the capsule.The handle appeared 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 crown overlap.A piece of calcification was visible on the base of the nosecone which coincided with the location of the capsule tip bump.The capsule tip bump was no longer visible following removal of the calcification.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The inner member shaft and spindle hub appeared intact with no evidence of damage.The reported event for vascular complications could not be confirmed in the analysis.Conclusion: fluoroscopic images and a computed tomography planning image of the stenosed access vessel, pre-implant valvuloplasty (piv) were provided for review.Fluoroscopic images showed the severely stenosed right femoral artery as described in the report.A successful piv was performed and multiple access vessel dilatations that finally led to a less constricted blood flow.Eventually, the report says due to extensive calcification and narrow vessel diameters in the access vessel, the procedure was aborted.Bleeding in the iliac arteries was observed which could subsequently be fixed with the implantation of two 8 millimeter (mm) covered stents.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 there was extensive calcification and narrow vessel diameters.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.Bleeding in the iliac arteries was observed.Vascular access related complications, such as bleeding, are known potential adverse patient effects per the evolut system instructions for use, and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Per the physician, the cause of the injury was dilatation of the iliac arteries.Per the physician, the dcs did not cause or contribute to the injury.There was no information to suggest 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.

• 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: 18248704
• MDR Text Key: 329505433
• Report Number: 2025587-2023-05017
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0011835067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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 Outcome(s): Required Intervention