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

Model Number ENVEOR-N

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the delivery catheter system (dcs) has not been returned for analysis; therefore, no product analysis has been per formed.Conclusion: without return of the product, no definitive conclusions could be drawn 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 attempted implant of a transcatheter bioprosthetic valve with this delivery catheter system (dcs), the valve was deployed too low and was recaptured.The valve was deployed a second time and again recaptured.During the second recapture, the capsule kinked.The valve was released a third time, but in the incorrect position.The valve was recaptured a third time but when the capsule was almost closed, the capsule broke.The valve was not fully recaptured as a small gap remained between the end of the capsule and the nose cone.The system was removed from the patient without injury.It was noted that the loader of the valve was inexperienced and in training.The valve and dcs were replaced.The implant of the new transcatheter bioprosthetic valve was performed successfully.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was returned with the capsule fully closed and the end cap/screw gear snap fit connected.The handle and the tip-retrieval mechanism appeared intact.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.Voids were observed along the full length of the capsule.The inner member shaft and spindle hub appeared intact with no evidence of damage.During an attempted load of a 34mm valve, the paddles fell out of the attachment pockets, and the capsule separated.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.Procedural images were submitted for review.The imaging confirmed the reported recaptures and confirmed a kink occurred during the second recapture.Various factors can affect valve positioning including patient anatomy or physician technique.Recapturing is a feature of the device that allows for additional attempts to accurately position the valve.The cause of the positioning difficulty could not be conclusively determined.The reported kink most likely describes the capsule buckle.The device was recaptured a third time and broke.Compressive forces can initiate a capsule buckle which can then result in a fracture in the capsule frame, and subsequently upon retraction, separate the capsule.Capsule separation typically occurs due to excessive compressive forces applied to the capsule.This excessive compressive force can be experienced when the valve is loaded incorrectly.It cannot be independently determined if the valve was correctly loaded onto the first dcs.The images provided confirmed one good valve load for this event, and based on the cine numbering, this load check was for the second valve that was implanted.Delamination was observed on the returned device, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy or if a valve has been misloaded.There is no information to suggest a device quality deficiency that may have caused or contributed to these events.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.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: 7643305
• MDR Text Key: 112565893
• Report Number: 2025587-2018-01614
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2019
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0008984409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR