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

Model Number ENVPRO-16

Device Problem Fracture (1260)

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

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with the valve loaded in the capsule of the dcs.The dcs handle appeared intact and the end cap/screw gear snap fit was connected.The dcs handle and tip-retrieval mechanism appeared intact and 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.Delamination was observed over the nitinol reinforcing frame near the separation site.A break was observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.The separation site was jagged and uneven.Conclusion: the investigation remains ongoing.Following completion of the investigation, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was successfully loaded and no misload was identified.The delivery catheter system (dcs) was used with the inline sheath.While placing the dcs in the native aortic valve, no resistance was detected.When the deployment knob was turned to deploy the valve, the capsule did not open, although tactile control had been felt.The dcs was removed from the patient and a capsule separation was noted.A new valve and dcs were used for implant.It was reported that there was calcification in the native annulus.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.Cines films were received for review.The cine films appeared to show a good valve load, however the cine did not show a full 360 degree rotation of the capsule.A review of the films could not confirm the event description that a capsule separation occurred.The cine films confirm the reported calcium on the patient¿s valve.There was no other evidence of damage observed on the subject dcs.Based on the investigation completed, there is no evidence that the product failed to meet specification and these events are most likely not related to a fault condition of the device.The exact root cause of capsule separation is unknown, however, patient anatomy (vessel tortuosity <(>&<)> calcification) and use conditions due to challenging anatomy (insertion angle, force required to advance, torqueing of the catheter) are known potential contributing factors to capsule damage.Updated data: eval method code, eval results code, and eval conclusion code.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: 8812817
• MDR Text Key: 151763656
• Report Number: 2025587-2019-02288
• 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: 10/15/2019

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: 10/03/2020
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0009358603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1