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

Model Number D-EVPROP2329US

Device Problem Failure to Advance (2524)

Patient Problems Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Cardiovascular Insufficiency (4445)

Event Date 04/23/2021

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve into a patient with a previously implant surgical aortic valve (sav), while attempting to advance the delivery catheter system (dcs) through the previous sav at the annulus, hemodynamic breakdown occurred.The dcs was not able to be advanced.It was reported that the dcs was an indirect cause of the hemodynamic breakdown.It was reported that the patient's blood pressure decreased, and acute aortic regurgitation (ar) occurred.The direct cause of the ar was an unknown guidewire.Ventricular fibrillation also occurred.The heart became intolerant to the exacerbation of ar.As a result, percutaneous cardiopulmonary support was introduced, and cardiopulmonary resuscitation (cpr) was initiated.The recovery of the patient was prioritized, and the valve implant attempt was aborted.Of note, it was reported that prior to the valve implant procedure, the patient's hemodynamics were originally poor.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: 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.

• Brand Name: EVOLUT PRO PLUS DCS
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13771794
• MDR Text Key: 287246101
• Report Number: 9612164-2022-01022
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010451636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/15/2022
• Date Device Manufactured: 11/11/2020
• 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): Life Threatening; Required Intervention