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

Model Number ENVEOR-US

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the product was discarded by the customer; therefore, no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.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 failed non-medtronic surgical aortic valve with aortic insufficiency, the capsule of the delivery catheter system (dcs) separated.The valve was loaded to an incompatible dcs size per physician request by an experienced loader with little resistance.The dcs was advanced through a 14 french sheath and tortuous anatomy.During deployment, tension was noted and the capsule opened 10mm prior to the separation.The dcs and valve were withdrawn from the body through a 20 french sheath.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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 reported event indicated that the capsule broke during deployment.Typically, capsule break/separation occurred due to excessive compressive forces applied during the valve loading process.This excessive compressive force was experienced when the valve was loaded incorrectly.In this case, it was reported that the valve was loaded onto an incompatible dcs size per the physician's request.The evolut system instructions for use (ifu) outlined the system compatibility; the evolut pro valve is compatible with the 20 fr enveor-n-us dcs model only, rather than the 18 fr enveor-us model that was used in this case.It cannot be determined if the incompatible dcs size caused or contributed to the capsule break.There was no information to suggest a device quality deficiency may have caused or contributed to this event, but a conclusive root cause cannot be determined at this time.The dcs and valve were withdrawn from the body and no adverse patient effects were reported.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
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7182357
• MDR Text Key: 96975842
• Report Number: 2025587-2018-00123
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169633353
• UDI-Public: 00643169633353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2018
• Device Model Number: ENVEOR-US
• Device Catalogue Number: ENVEOR-US
• Device Lot Number: 0008647677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Date Device Manufactured: 05/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 90 YR