MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number HC15025

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Insufficiency (2022); Pulmonary Valve Stenosis (2024)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.No product was returned.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 4 years 5 months post implant, a 25mm pulmonary valved conduit was replaced valve-in-valve with a transcatheter pulmonary valve.The reason for replacement was reported as severe pulmonary stenosis and moderate pulmonary insufficiency.No additional adverse patient effects were reported. .

• Brand Name: HANCOCK
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 10304880
• MDR Text Key: 199847087
• Report Number: 2025587-2020-02286
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490908832
• UDI-Public: 00681490908832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790007
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: HC15025
• Device Catalogue Number: HC15025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2020
• Date Device Manufactured: 09/29/2014
• 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: 18 YR
• Patient Weight: 85