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

Model Number ENVPRO-16

Device Problems Fracture (1260); Difficult to Advance (2920); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  malfunction  

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 prior to the attempted implant of a transcatheter bioprosthetic valve, with this delivery catheter system (dcs), the dcs was inserted with the inline sheath without issue.It was noted that the anatomy was tortuous, as there was a slight s-looking kink in the abdominothoracic aorta, as well as an acute-angled kink in the transition from the aortic arch to the descending aorta.The anulus was angiographic very horizontal and was calcified.Difficulty was encountered when the dcs was advanced past the heavy kink, prior to the aortic arch.Following the first deployment of the valve, the valve was recaptured due to a deep placement upon partial deployment.Immediately following the recapture, a capsule fracture was identified.The system was successfully removed without issue and was replaced with a non-medtronic device.A non-medtronic valve was implanted.Following the implant procedure, the outcome was good results.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the valve was received loaded in the capsule of the delivery catheter system (dcs).The handle appeared intact.The device was received with the capsule partially opened.The device was returned with the end cap/screw gear snap fit connected.Delamination was observed over the nitinol reinforcing frame along the mid-section to the distal end of the capsule.Damage was noted on the nitinol frame near the proximal end of the capsule.On attempted retraction of the capsule, the damage on the nitinol frame was stretched.The valve could not be removed from the dcs, and analysis could not be performed.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: 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.Difficulties advancing the delivery catheter system (dcs) through the vasculature is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.Various factors can affect valve positioning including the patient anatomy or physician technique.Recapturing is a feature of the envpro device that allows for additional attempts at accurately positioning the valve.In this case, it was noted that the anatomy was tortuous, as there was a slight s-looking kink in the abdominothoracic aorta, as well as an acute-angled kink in the transition from the aortic arch to the descending aorta.Also, the anulus was very horizontal and was calcified.This indicates that the probable cause of the advancement and positioning difficulty was patient anatomy.Advancement and positioning difficulties do not typically indicate a device manufacturing issue.Delamination was observed over the nitinol reinforcing frame along the mid-section to the distal end of the capsule.Delamination between the capsule outer polymer and the nitinol frame, typically occurs when the capsule is subjected to a bending force.Delamination may occur over the spindle/paddle interface if a valve has been misloaded; however, it may also occur due to tracking/positioning in the patient anatomy.Given the event description, the source of this delamination is most likely due to the anatomy.Capsule stretching, and separation occurs due to excessive compressive forces applied to the capsule.Forces in the system is a cumulative effect that may be increased by factors such as tortuous anatomy and load quality.In this case, it was noted that the anatomy was tortuous, as there was a slight s-looking kink in the abdominothoracic aorta, as well as an acute-angled kink in the transition from the aortic arch to the descending aorta.Also, the anulus was very horizontal and was calcified.Based on the investigation completed there is no evidence that the product fails to meet specification and these events are most likely not related to a fault condition of the device.The exact root cause of these capsule separations is unknown however, it is proposed, based on a review of the complaint information, that patient anatomy (vessel tortuosity <(>&<)> calcification) and use conditions due to challenging anatomy (insertion angle, force required to advance, torqueing of the catheter) are potential contributing factors to capsule damage.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 DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8696181
• MDR Text Key: 147912014
• Report Number: 2025587-2019-01919
• 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,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2021
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0009635358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 06/21/2019; 09/20/2019
• Supplement Dates FDA Received: 07/01/2019; 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR