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

Model Number ENVPRO-16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that at the end of the implant procedure of a 26mm transcatheter bioprosthetic valve, with this delivery catheter system (dcs) via right femoral artery access, a dissection was noted at the access site in the common femoral artery and 6mm above.The dissection was not flow limiting; a non-medtronic balloon-expandable stent was placed.It was reported that two non-medtronic closure devices and a non-medtronic introducer sheath were used during the valve implant procedure.Per the physician, it was very difficult to relate the dissection to a specific device; the most probable cause is the non-medtronic closure device, but a relationship with the dcs cannot be excluded.It was noted that a computed tomography scan performed prior to the valve implant showed an unspecified artery disease.No additional adverse patient effects were reported.

• Brand Name: ENVEO PRO 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: 9176908
• MDR Text Key: 167643054
• Report Number: 2025587-2019-03102
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2021
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0009583101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• Date Device Manufactured: 02/08/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 75