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

Model Number D-EVOLUTFX-34

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208)

Event Date 12/07/2022

Event Type  Death  

Event Description

Medtronic received information that during the attempted implant of this transcatheter bioprosthetic valve into a patient with an existing abdominal aortic aneurysm (aaa) endurant stent graft, the delivery catheter system (dcs) was unable to advance into the patient¿s anatomy.A second attempt was made.The physician¿s attempt to advance the second valve and the dcs into the patient¿s anatomy was unsuccessful.It was noted the patient¿s blood pressure dropped.Upon investigation of the legs via angiogram, the physician noted the right iliac artery under the aaa stent graft was ruptured.Subsequently, four stents were placed successfully, and the patient was stabilized.One day following the valve implant procedure, the patient died in the intensive care unit.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: envpro-16-us, serial/lot #: (b)(4), ubd: 24-sep-2023, udi#: (b)(4).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.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 which confirmed that the patient's cause of death was the rupture of the iliac and femoral artery.According to the physician, the vessel serial dilation caused the initial injury to the iliac artery.Subsequently, then the insertion and removal of the dcs further contributed to the rupture.The physician believed that the rupture got progressively worse as the team continued to advance and remove devices from the patient's vessel.It was reported that the dcs was not able to advance past the aortic bifurcation.Of note, the patient had severe athlerosclerosis, stenosis, and calcium build up, all of which are believed to have contributed to the advancement issues.

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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the device was received with the nosecone over-captured by the capsule.On retraction of the capsule via the rotation of the deployment knob, the original valve deployed without issue.The trigger moved to fully advance and retracted positions and locked in place when released.The handle and tip-retrieval mechanism were intact.The device was returned with the end cap/screw gear snap fit connected.Light delamination was observed over the nitinol reinforcing frame along the distal section to the proximal end of the capsule.The inner member shaft and spindle hub were intact with no evidence of damage.There was a bend along the length of the stability shaft.There was a bulge to the capsule with two nitinol protrusions at the site of the bulge.Conclusion: the subject delivery catheter system (dcs) was returned for analysis.The device was received with the nosecone over-captured by the capsule.The device instructions for use (ifu) cautions the user to ¿stop advancing the capsule once the gap to the catheter tip is closed.Advancing the capsule farther could damage the capsule¿.On retraction of the capsule via the rotation of the deployment knob, the original valve deployed without issue.Light delamination was observed over the nitinol reinforcing frame along the distal section to the proximal end of the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.There was a bend along the length of the stability shaft, however, the description of the event does not indicate that this damage occurred during the reported issue.Bent catheter shafts have historically been observed when the device was returned for analysis coiled in a box, as was observed in this case.There was a bulge to the capsule with two nitinol protrusions at the site of the bulge.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.However, the root cause cannot be conclusively determined with the information available.The reported events for death-related, unable to advance, hypotension, and rupture could not be confirmed in the analysis.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 severe athlerosclerosis, stenosis, calcium build up and an existing abdominal aortic aneurysm stent graft.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.Hypotension is a known potential adverse effect per device ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally functioning device or model implant procedure, and a conclusive cause could not be determined from the limited information available.Vascular complications, such as rupture, are a known potential adverse patient effect per the device ifu, and are typically related to patient factors (anatomy, comorbidities, etc.), and/ or procedural effects (sheath used, user technique, puncture cut location, etc.).According to the physician, the vessel serial dilation caused the initial injury to the iliac artery.Subsequently, then the insertion and removal of the dcs further contributed to the rupture.The physician believed that the rupture got progressively worse as the team continued to advance and remove devices from the patient's vessel.There is no information to suggest that a device malfunction or a failure to meet manufacturing specifications was related to these events.One day following the valve implant procedure, the patient died in the intensive care unit.It was reported that the patient's cause of death was the rupture of the iliac and femoral artery.Based on the information provided, the relationship of the dcs to the event is possibly related.Possible contributing factors could be the patient¿s anatomy: atherosclerosis/ stenosis and/ or pre-existing aaa stent graft with possible angulation at the distal limb.The primary event of vascular rupture resulted in the secondary/cascading events of hypotension and death.These events are not unexpected therefore no further actions are needed.Updated: d9, h3, 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.

• 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: 16053178
• MDR Text Key: 306190008
• Report Number: 2025587-2022-03709
• Device Sequence Number: 1
• Product Code: NPT
• 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,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0011454411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Sex: Male