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

Model Number D-EVPROP34US

Device Problem Failure to Advance (2524)

Patient Problems Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)

Event Date 02/22/2022

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.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 into a patient with bilateral iliac stents, the left iliac artery was dilated and an 18fr sheath was able to advance through the iliac stent.The delivery catheter system (dcs) was attempted to advance through the very distal end of the iliac stent however was unsuccessful.The dcs was removed and the procedure was aborted.After the system was removed, the patient became hemodynamically unstable and required chest compressions.It was determined that a dissection occurred in the left common femoral artery.A balloon was placed to occlude the blood floor and the patient regained normal blood pressure.A cutdown was performed and the left common femoral artery was repaired.Per the physician, the dcs caused the injury.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the capsule appeared intact with no evidence of damage.The device was received with the capsule fully closed.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advance and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The device was returned with the end cap/screw gear snap fit connected.The inner member shaft and spindle hub appeared intact with no evidence of damage.The cause of the unable to advance event could not be determined via analysis of the device.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

Conclusion: a device history record (dhr) review was performed on the delivery catheter system (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 subject dcs was returned to medtronic for analysis.There was no evidence of damage to the device.The cause of the unable to advance event could not be determined via analysis of the device.Difficulties advancing the dcs through the vessel is known to be related to factors such as patient anatomy and physician technique.In this case, it was noted that the patient had bilateral iliac stents and the dcs could not advance through the very distal end of the iliac stent.This indicates that the probable cause of the advancement difficulties was due to interaction with the iliac stent.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Vascular access related complications, such as dissection are a known potential adverse patient effect per the evolut pro + system i nstructions for use (ifu), 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 dcs caused the injury, however, based on the limited evidence available the cause of the dissection and the relationship to the dcs could not be conclusively confirmed.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.Hemodynamic instability is typically related to patient factors, and/or procedural effects (sheath used, user technique, closure device, etc.), however, an assignable root cause could not be determined given the limited information available.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: 13859927
• MDR Text Key: 287664869
• Report Number: 2025587-2022-00763
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: D-EVPROP34US
• Device Catalogue Number: D-EVPROP34US
• Device Lot Number: 0010391351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 04/25/2022; 05/17/2022
• Supplement Dates FDA Received: 05/16/2022; 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2020
• 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): Required Intervention; Life Threatening
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 61 KG