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

Model Number ENVEOR-N

Device Problems Fracture (1260); Difficult to Advance (2920); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the device was received with the capsule fully closed.The handle was intact.The deployment knob retracted and advanced the capsule.The trigger moved to fully advance and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.The device was returned with the end cap/screw gear snap fit connected.A fracture was observed on the proximal end of the capsule.Voids were observed along the proximal end of the capsule.The spindle hub was intact with no evidence of damage.From close observation, damage was noted to the inner member shaft near the spindle hub.Conclusion: results pending completion of the investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve, into a patient with a very calcified ilio-femoral axis, forced was reported to have been applied to advance the delivery catheter system (dcs).However, once at the iliac axis, resistance was met and the capsule of the delivery catheter system (dcs) kinked and partially fractured.The system was removed from the patient.The same valve was loaded on to a different dcs and was successfully deployed.No adverse patient effects were reported.

Manufacturer Narrative

Difficulty advancing the delivery system through patient vessels was typically related to procedural factors (sheath used, technique, guidewire, etc,) and/or patient anatomical effects (calcification, tortuousity, vessel diameter, etc.); review of procedural imaging confirmed the reported inability to advance the dcs through patient iliacs, and also showed calcification that may have played a primary role leading to this event.There was no information to suggest a device quality deficiency related to this event.The cine films confirmed that the vessels were very calcified and that they were unable to advance the first catheter.They also showed that the second dcs was inserted and the valve was successfully deployed.The subject device was received and evaluated by medtronic; the dcs showed no abnormalities except for a fracture on the proximal end of the capsule, and voids along the proximal end of the capsule.From close observation, damage was noted to the inner member shaft near the spindle hub.Capsule separation typically occurred due to excessive compressive forces applied during the valve loading process.This excessive compressive force was typically experienced when the valve was loaded incorrectly.However, no fluoroscopic load check images were submitted for review, therefore it cannot be independently determined if the valve was correctly loaded onto the dcs.The valve was implanted successfully in this case.The valve was removed from the dcs and loaded onto a new dcs for a successful implant and no further patient effects were reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7733452
• MDR Text Key: 115653540
• Report Number: 2025587-2018-01936
• 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: 10/04/2018

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: 05/10/2019
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0009137074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 08/08/2018
• Supplement Dates FDA Received: 08/24/2018; 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR