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 Code	Shelf Life Exceeded (1567)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The two delivery catheter system (dcs) (lot number 0008473150) were discarded by the customer, therefore no product analysis could be performed.Conclusion: without return of the products, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, two delivery catheter systems (dcs) used for implant had expired two days prior to the procedure.Both dcs were from hospital owned stock and there were no other dcs on site.The physician was made aware of the use of expired product.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: 7280146
• Report Number: 2025587-2018-00406
• Device Sequence Number: 1177507
• Product Code: NPT
• UDI-Device Identifier: 00643169640337
• UDI-Public: 00643169640337
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008473150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 81 YR
• Patient Weight: 65