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); Fracture (1260); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis: upon receipt at medtronic's quality laboratory, the capsule and a portion of the middle member and outer shaft of the delivery catheter system (dcs) were received for analysis.The rest of the dcs was not returned.Delamination was observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.A break was observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.Conclusion: the investigation is in progress.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bioprosthetic valve, into a patient with aortic insufficiency, the valve was recaptured four times.The system was withdrawn from the patient and a new valve and delivery catheter system were used for implant.No adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the lot number of the subject delivery catheter system (dcs) is not known, and therefore a device history record (dhr) review could not be performed on the dcs.However, manufacturing controls are in place to ensure that the device met specification requirements prior to release from the manufacturing facility.The reported event indicates that the valve was recaptured four times, however the reason for the recaptures was not reported.The evolut system instructions for use (ifu) instructs "deployment of the bioprosthesis can be attempted 3 times.If the bioprosthesis is recaptured a third time, it must be removed from the patient".Recapturing is a feature of the evolut system that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique but the cause of the potential positioning difficulty could not be conclusively determined with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.The capsule and a portion of the middle member and outer shaft was returned to medtronic for analysis.The remainder of dcs was not returned.The dcs may have been severed at the outer shaft after the event occurred, however based on the event description, it cannot be determined why or how the device was severed.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through patient anatomy.Additionally, there was a break observed at the proximal end of the nitinol frame of the capsule.The investigation completed into capsule separation found that 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 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.The four recaptures, outside ifu recommenda tion, may have also contributed to the capsule damage.However, as no capsule damage was reported in the event, the cause of the damage cannot be determined.It was reported that the system was removed and a new valve and dcs were used for implant.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: 9782340
• MDR Text Key: 182004967
• Report Number: 2025587-2020-00664
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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 Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR