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

Model Number EVOLUTPRO-29-US

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Intimal Dissection (1333)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: evproplus-29us, serial/lot #: (b)(4), ubd: 23-feb-2022, udi#: (b)(4).Product analysis: both valves remain implanted, therefore no product analysis can be performed.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 during the implant of this 29 millimeter (mm) transcatheter bioprosthetic valve, after deployment, the valve dislodged.A second 29 mm transcatheter valve was loaded onto a second delivery catheter system (dcs).After deployment, the second valve also dislodged.The anatomy was reported as calcified and snaring of the dislodged valves was not required.A non-medtronic valve was subsequently implanted valve-in-valve within the two medtronic transcatheter valves.A dissection from the sinus up to the right subclavian occurred, which was treated using surgical repair.It was reported that valve manipulation and dislodgements may have contributed to the dissection.No additional adverse patient effects were reported.

• Brand Name: EVOLUT PRO TRANSCATHETER AORTIC 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10559595
• MDR Text Key: 207703339
• Report Number: 2025587-2020-02869
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000017835
• UDI-Public: 00763000017835
• 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
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: EVOLUTPRO-29-US
• Device Catalogue Number: EVOLUTPRO-29-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• Date Device Manufactured: 04/16/2019
• 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: 82 YR