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

Model Number HC15022

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

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

Event Date 03/23/2020

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 13 years and 7 months post implant of this 22mm pulmonary valved conduit in a (b)(6)-year-old pediatric patient, it was replaced valve-in-valve with a transcatheter bioprosthetic pulmonary valve deployed to 22mm.The reason for replacement was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the pulmonary valved conduit was replaced due to moderate-to-severe stenosis with a peak gradient of 60mmhg.Mild pulmonary insufficiency was also reported.It was reported that the patient was symptomatic prior to valve replacement.No additional adverse patient effects were reported.  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: 9968799
• MDR Text Key: 187925344
• Report Number: 2025587-2020-01296
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490908818
• UDI-Public: 00681490908818
• Combination Product (y/n): N
• PMA/PMN Number: P980043
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HC15022
• Device Catalogue Number: HC15022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR