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

Model Number HC15025

Device Problems Gradient Increase (1270); Insufficient Information (3190)

Patient Problems Pulmonary Insufficiency (2022); Pulmonary Valve Stenosis (2024); No Information (3190)

Event Date 04/26/2019

Event Type  Injury  

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.

Event Description

Medtronic received information that 26 years 4 months post implant of this 25mm pulmonary valved conduit, it was replaced valve-in-valve with an 18mm transcatheter pulmonary valve for unknown reasons.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the 25mm pulmonary valved conduit was replaced due to moderate stenosis, severe insufficiency, and increased gradients (27mmhg).It was reported the patient was an extremely poor surgical candidate and, therefore, required replacement with a transcatheter pulmonary valve.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 8624346
• MDR Text Key: 145520454
• Report Number: 2025587-2019-01637
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490908832
• UDI-Public: 00681490908832
• Combination Product (y/n): N
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

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
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 77