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

Model Number ENVEOR-N

Device Problem Failure to Advance (2524)

Patient Problem Intimal Dissection (1333)

Event Date 01/22/2020

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 prior the implant of this transcatheter bioprosthetic valve via right femoral access, a 20 medtronic received information that prior the implant of this transcatheter bioprosthetic valve via right femoral access, a 20 french non-medtronic introducer sheath was inserted, but was unable to be advanced through the right femoral artery.The 20 french sheath was withdrawn and a 16 french inline sheath was inserted through the right femoral artery, but was also unable to be advanced.It was reported that the minimum diameter of the access vessel was 5.4 millimeter (mm).The 20 french introducer sheath and dcs were inserted again, and the iliac artery was passed with resistance.The valve was successfully implanted.Following the valve implant, after the sheath was removed, it was noted that a dissection occurred.The dissection was repaired with a percutaneous peripheral intervention and vascular exposure.Per the physician, the small blood diameter and blood vessel fragility may have contributed to the injury.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device was not returned for analysis, nor were any cine images available for review.A device history review is not required as the product event does not indicate a potential manufacturing issue.Difficulties advancing the delivery catheter system (dcs) through the vasculature is known to be related to factors such as patient anatomy (angulation, calcification, tortuousity, etc) and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that the patient had small blood diameter and blood vessel fragility.In addition, it was noted that the minimum access vessel diameter was 5.4 mm.As per the evolut pro system instructions for use (ifu), when using the enveor-n, ¿patients must present with transarterial access vessels with diameters that are =5.5 mm¿.This indicates that the probable cause of the advancement difficulties was narrow patient anatomy.Advancement difficulties do not typically indicate a device issue.Vascular related complications, such as dissection are a known potential adverse patient effect per the evolut pro ifu, and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Based on the limited information available, an assignable root cause of the vascular complication cannot be determined and the relationship to the dcs could not be established.In this case, it was noted that per the physician, the small blood diameter and blood vessel fragility may have contributed to the injury.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Updated data: h.6 - eval results, eval conclusion codes.Corrected data: d.1 - brand name and d.4 - model/lot number.The lot number was omitted in error.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 R DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10295801
• MDR Text Key: 199491834
• Report Number: 2025587-2020-02266
• 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: 10/05/2020

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: 06/05/2020
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0009774181
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention