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

Model Number	ENVEOR-N-US
Medical Device Problem Codes	Difficult To Position (1467); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at medtronic¿s quality laboratory, the device was received with the capsule fully closed.The deployment knob retracted and advanced the capsule.The trigger moved to fully advanced 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 3.5mm gap was observed between the distal edge of the capsule and the catheter tip of the inner member assembly.Several voids were observed over the nitinol reinforcing frame at the distal end and proximal end of the capsule.The proximal end of the capsule was observed to be separated.Conclusion: a lot history record (lhr) review was performed on the delivery catheter system (dcs) and there were no correlations/issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The event indicated that, during deployment, the capsule separated.Fluoroscopic images were submitted by the account and confirmed the capsule separation.The delivery catheter system was returned for analysis; the capsule was observed to be separated.Additionally, voids were observed on the capsule, which indicated delamination between the capsule outer polymer and the nitinol frame.Voids typically occur when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy, or if a valve has been misloaded.Capsule separations typically occurs due to excessive compressive forces applied during the valve loading process.This excessive compressive force is only experienced when the valve is loaded incorrectly.No fluoroscopic load check image/cine was submitted for review.Therefore it cannot be independently determined if the valve was correctly loaded onto the delivery catheter system.
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, a non-medtronic introducer sheath was inserted.The delivery catheter system (dcs) nosecone and capsule were twisted to advance through the sheath.Additional twisting occurred to advance the system through the tortuous anatomy.Upon the attempt at deployment, a capsule separation was noted and the dcs was unable to deploy the valve.The dcs was withdrawn from the body.The nose cone and inner cannula held the capsule on the dcs as it was removed.A second valve was loaded to a second dcs and used for implant.No adverse patient effects were reported.

• Brand Name: ENVEO R DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• MDR Report Key: 7117528
• Report Number: 2025587-2017-02435
• Device Sequence Number: 16423776
• Product Code: NPT
• UDI-Device Identifier: 00643169640337
• UDI-Public: 00643169640337
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008450383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 88