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

Model Number ENVPRO-16

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981); Noise, Audible (3273)

Patient Problems Calcium Deposits/Calcification (1758); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product analysis: the device has been returned and the results of the analysis are pending.Conclusion: without the results of the analysis, 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 a transcatheter bioprosthetic valve, into an annulus with severe calcification and calcified access vessel, a pre-balloon aortic valvuloplasty (bav) was performed.This delivery catheter system (dcs) was inserted and could not pass the right common iliac artery due to calcification and kinking.A 16 fr sheath was used and with force and the dcs was introduced through the vessel and into an annular position for deployment.The valve was 2/3 deployed and the valve dislodged into the ascending aorta.The valve was recaptured and the dcs made a "knock" noise.The deployment knob was all the way closed, however the capsule was still 1 cm open due to the capsule being bent behind the paddles and there was protusion of the dcs shaft.The dcs was removed.A new valve was loaded onto a new dcs and was implanted successfully.No 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.Difficulties advancing the dcs through patient anatomy is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity).In this case, calcification in the anatomy was reported.This indicates that the most likely cause of the advancement difficulties was challenging patient anatomy.Potential factors that can influence dislodgement include tension applied on the dcs during positioning, calcification levels and shape of the native anatomy.Procedural films were provided for review, however there was no imaging showing the dislodgement.The cause of the reported dislodgement could not be conclusively determined with the information available.Dislodgement events do not typically indicate a device malfunction or a failure to meet manufacturing specifications.The procedural films did not show the recapture and therefore the reported bent capsule and protrusion of the dcs shaft could not be confirmed via the cine review.Delamination observed on the capsule of the returned dcs typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.Capsule 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.Fluoroscopic load checks were submitted for review, however a good load can only be confirmed for 2 of the 3 load checks submitted.The cause of the capsule separation cannot be conclusively determined based on the information available.The protrusion of the dcs shaft reported in this event is most likely the spine wire break.When the handle was turned during analysis, the capsule did not respond.This was due to the spine wire break.When the spine wire breaks the force from the handle is not transmitted to the capsule.Historically, torquing or manipulation of the dcs against the spine wires by the user may cause the spine wire to break.The instructions for use (ifu) instructs the user not to rotate the dcs as is being advanced.The torsion marks observed on the dcs further indicate that the dcs was torqued during use.However, the cause of the spine break cannot be conclusively determined with the 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.

Manufacturer Narrative

Analysis: upon receipt at medtronic's quality laboratory, the valve was received in the capsule of the delivery catheter system (dcs).The handle appeared intact.The device was received with the capsule partially opened.The capsule does not respond when attempting to advance or retract using the deployment knob.The capsule does not respond when attempting to advance or retract using the trigger.The tip retrieval mechanism does not retract the capsule.The device was returned with the end cap/screw gear snap fit connected.Delamination was observed over the nitinol reinforcing frame along the full length of the capsule.There was a break observed in the capsule nitinol reinforcing frame near the proximal end of the capsule, the capsule was held together by the outer layer of polymer.Torsion marks were observed on the outer shaft of the dcs.The spine of the dcs was broken approximately 36cm from the strain relief.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: 8353952
• MDR Text Key: 136859910
• Report Number: 2025587-2019-00660
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2020
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0009325500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR