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

Model Number ENVPRO-16

Device Problems Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the delivery catheter system (dcs) has not been returned; therefore, no product analysis can be performed.Conclusion: without return of the products, 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 implant of a 34-millimeter (mm) transcatheter bioprosthetic valve with this delivery catheter system (dcs), the valve was deployed twice and recaptured three times.On all three deployments, the valve was placed in the annulus and it dislodged into the ventricle.The valve dislodged due to less calcium in the annulus and the horizontal aorta.On the third recaptured a third time and the capsule broke.The valve was able to be fully recaptured and the system was removed.The valve and delivery catheter system (dcs) were replaced and another 34-mm transcatheter bioprosthetic valve was implanted.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 deployment knob appeared to retract and advance the capsule.The trigger moved to fully advance and retracted positions and locked in place when released.The device was returned with the end cap/screw gear snap fit connected.There was a break observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.Delamination was observed over the nitinol reinforcing frame near the separation site.Part of the nitinol wiring was exposed at the separation site.The separation site was jagged and uneven.At this point the deployment knobs were separated by the analysis technician.Tab 3 appeared to have a hairline fracture at the point where the tab protrudes from the deployment knob.Tab 4 appeared to have a stress mark at the point where the tab protrudes from the deployment knob.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: it was reported that the valve dislodged and was recaptured.Potential factors that can influence dislodgement include tension applied on the delivery catheter system (dcs) during positioning, calcification levels and shape of the native anatomy.In this case, it was reported that there was less calcium in the annulus and the patient had a horizontal aorta, which are factors that may have caused or contributed to the dislodgement event.Dislodgement events do not typically indicate a device malfunction or a failure to meet manufacturing specifications.On the third recapture, the capsule broke.The dcs was returned for analysis.The capsule was observed to be separated at the proximal end, confirming the reported event.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.No procedural images or fluoroscopic load check images were submitted for review.The cause of the capsule separation cannot be determined based on the information available.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.Additionally, the handle of the returned device was observed to be loose.The analysis technician separated the handle with little resistance.The snap fit tabs of the actuator were observed to be damaged.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.The reported event did not indicate that an actuator separation occurred during the reported issue, and the actuator may have been damaged during returned transport for analysis there is no information to suggest a device quality deficiency that may have caused or contributed to this event.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 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: 8203193
• MDR Text Key: 131718808
• Report Number: 2025587-2018-03572
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2020
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0009334440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 85