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

Model Number ENVEOR-N

Device Problems Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problem Hematoma (1884)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id {evolutpro-29}; product lot/serial number (b)(6).Product type: {transcatheter aortic valve (tavr)}; implant date {na}; explant date {na} product id {ls-mdt2-2629}; product lot/serial number (b)(6).Product type: {compression loading system (cls)}; implant date {na}; explant date {na} product id {edwards}; product lot/serial number {unknown}; product type: {transcatheter aortic valve (tavr)}; implant date (b)(6) 2018 explant date {na}.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 the implant of this transcatheter bioprosthetic valve, the valve was recaptured three times for repositioning.After the point of no return, the valve dislodged towards the left ventricular outflow tract (lvot) despite tension regulation and pacing.It was reported that it was most likely due to the traction of the system by calcification and the tortuosity of the iliac vessel.The valve was not implanted and a non-medtronic valve was implanted.No adverse patient effects were reported.Additional information was reported that following the attempted implant of this transcatheter bioprosthetic valve and the implant of a non-medtronic valve, a hematoma of the left groin was identified.Minimal drop in hemoglobin levels were observed and no transfusion was required.The only treatment for the hematoma was a pressure bandage.Per the physician, the hematoma was not related to any medtronic device, but was related to the procedure.The hematoma resolved two days after onset.No adverse patient effects were reported.

• Brand Name: ENVEO R DELIVERY SYSTEM
• 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: 19153711
• MDR Text Key: 341565364
• Report Number: 2025587-2024-02418
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2019
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0008982192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 02/05/2018
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Weight: 84 KG