MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number EVPROPLUS-29US

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 09/29/2020

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: d-evprop2329us, lot #: 0010149002, ubd: 23-feb-2021, udi#: (b)(4).Product id: d-evprop2329us, lot #: unknown, ubd: unknown, udi#: unknown.Product analysis: the valve and the delivery catheter systems (dcs) were not returned therefore no product analysis can be performed.Conclusion: without return of the products, 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 during the implant of this transcatheter bioprosthetic valve, the valve was deployed at ¾ depth and during removal of the delivery catheter system (dcs) nose cone the valve dislodged.Implantation of a second valve was attempted, but as the new dcs was going through the initial valve, the dcs got caught on the initial valve and bent the initial valve.The patient¿s blood pressure diminished.The patient¿s chest was prepped and a perforation was found in the ascending aorta but was unable to be repaired.Per the physician the perforation was caused by the bent valve.The patient passed away.

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.Dislodgement of the valve by the distal tip is related to operator technique or experience.The device instructions for use instructs ¿under fluoroscopic guidance, confirm that the catheter tip is coaxial with the inflow portion of the bioprosthesis¿ prior to drawing the delivery catheter system (dcs) tip through the valve.No images from the procedure were received for review.Given the limited information, the root cause of the dislodgement event cannot be confirmed.Events of this type do not indicate a device malfunction or a failure to meet manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVOLUT PRO PLUS VALVE
• 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: toni o'doherty ; parkmore business park west; galway, MN ; EI ; 7635055378
• MDR Report Key: 10737694
• MDR Text Key: 213156640
• Report Number: 2025587-2020-03228
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000211127
• UDI-Public: 00763000211127
• 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
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: EVPROPLUS-29US
• Device Catalogue Number: EVPROPLUS-29US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• Date Device Manufactured: 12/10/2019
• 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): Death; Required Intervention
• Patient Age: 75 YR