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

Model Number HC15025

Device Problem Gradient Increase (1270)

Patient Problems Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains 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 25 years and 4 months post implant of this 25mm pulmonary valved conduit, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The reason for replacement was reported as pulmonary stenosis with a 33mmhg gradient and moderate to severe pulmonary regurgitation.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11436144
• MDR Text Key: 238367281
• Report Number: 2025587-2021-00779
• 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: 03/08/2021

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 Model Number: HC15025
• Device Catalogue Number: HC15025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/08/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR