MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number ENVPRO-14

Device Problem Failure to Advance (2524)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device was discarded, therefore no product analysis can be performed.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 the implant of this transcatheter bioprosthetic valve, into a patient with calcified femoral arteries, the 14 fr sheath was advanced.The delivery catheter system (dcs) was inserted and attempted to be advanced but could not be advanced past the femoral puncture site.The dcs was attempted to be removed, however was wedged in the vessel against calcium.A femoral artery cutdown was performed but the dcs was unable to be removed as the nosecone was caught higher in the anatomy.After rotating the dcs and with slight rotations in the deployment knob to release the nosecone from the capsule, the system was successfully removed.An endarterectomy and surgical patch repair were performed due to femoral artery bleeding.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The reported event indicates that delivery catheter system (dcs) was unable to be advanced past the femoral puncture site.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, a cause of the difficulties was unable to be determined given the limited information available.A femoral artery cutdown was performed but the dcs was unable to be removed as the nosecone was caught higher in the anatomy.An endarterectomy and surgical patch repair were performed due to femoral artery bleeding.Vascular access related complications, such as bleeding, are a known potential adverse patient effect per the evolut system instructions 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.).There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Complaints for this event type are reviewed and no further action is recommended at this time.Updated data: method, results, and conclusion codes.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: ENVEO PRO DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11920208
• MDR Text Key: 253728082
• Report Number: 2025587-2021-01749
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

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: 12/14/2022
• Device Model Number: ENVPRO-14
• Device Catalogue Number: ENVPRO-14
• Device Lot Number: 0010491101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR