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

Model Number D-EVPROP34

Device Problems Failure to Advance (2524); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id evproplus-34 (serial: (b)(6)); product type: 0195-heart valves.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the right femoral artery was chosen as the access vessel.A pre-implant balloon aortic valvuloplasty (bav) was performed using a 23 mm non-medtronic vacs ii balloon.The guidewire selected for this case was a non-medtronic lunderquist doublecurved wire.After accessing the groin, when passing the delivery catheter system (dcs), the dcs was not able to advance further than the common iliac artery due to circular calcification.Attempts were made to pass the vessel.A 8 mm percutaneous transluminal angioplasty (pta) balloon was inflated to dilate the vessel.Following the dilation, the dcs was still not able to be advanced.Per the physician request, the access was moved to the left groin.On the left side however, the same issues occurred.Advancing past the common iliac artery was not possible due to the calcification.A pre-dilation of the vessel was made using a 20 fr sentrant sheath.During the dilation, the loader noticed that the capsule metal layer had poked through the capsule "pu" layer.The entire system was discarded.A replacement valve was loaded onto a new system and was able to be deployed successfully.No adverse patient effects were reported.

Manufacturer Narrative

Updated b5.Updated h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received which reported that a 30 minute procedural delay occurred.

• 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: 18944205
• MDR Text Key: 339206030
• Report Number: 2025587-2024-01791
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-EVPROP34
• Device Catalogue Number: D-EVPROP34
• Device Lot Number: 0012033817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Date Device Manufactured: 07/01/2022
• 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
• Treatment: SEE H11.
• Patient Age: 84 YR
• Patient Sex: Male