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

Model Number ENVEOR-N

Device Problems Material Separation (1562); Activation Failure (3270); Noise, Audible (3273)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, the valve was received loaded in the capsule of the delivery catheter system (dcs).The deployment knob does not appear to retract and advance the capsule.The trigger does not move to fully advanced or retracted positions.The device was returned with the end cap/screw gear snap fit connected.Damage was noticed on the threading of the screw gear.The front grip of the handle was observed to be separated.Several voids were observed over the nitinol reinforcing frame along the mid-section to the proximal end 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this 34mm transcatheter bioprosthetic valve, using transfemoral access, the blue handle of the delivery catheter system (dcs) turned with unusual difficulty.When attempting to release the valve, at slightly more than 80% of deployment, the paddles remained connected and did not separate.The capsule could not be opened and audible ¿clicking¿ sounds were heard from the dcs handle.Since the valve could not be released, it was recaptured and removed from the patient.It was reported that the loading was performed by experienced hospital staff with no resistance noted, but a few attempts were required to adequately place the paddles and load the valve.The loading was confirmed with visual, tactile, and fluoroscopic inspection.It was reported that the fluoroscopic inspection was performed too quickly with a rotation of two seconds.When the procedural video was reviewed following the procedure, a misload was noted due to one of the paddles not in place which was believed to likely contribute to the inability to release the valve.Subsequently, a second valve was loaded onto a new dcs and was successfully implanted.No adverse patient effects were reported.

Manufacturer Narrative

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.The damage observed on the returned device is consistent with excessive force applied on the system.In this case, it was reported that review of the fluoroscopy load check, after the procedure, showed a misloaded valve, which was not detected during the pre-implant load check.No images were provided to assess the quality of the load.Difficulty or inability to release the valve from the delivery catheter system (dcs) at 80% deployment is typically related to excessive force applied on the system, which can be caused by several factors such as a misloaded valve, patient anatomy, user technique, etc.Capsule separation typically occurs due to excessive compressive force applied during the valve loading process.This excessive compressive force is only experienced when the valve is loaded incorrectly.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: 7715290
• MDR Text Key: 115191535
• Report Number: 2025587-2018-01847
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2018
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0008812607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR