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

Model Number HA24227H

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

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

Event Date 04/28/2011

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 10 years post implant of this pulmonary valved conduit, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The reason for intervention was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the valve was replaced due to insufficiency, stenosis, and a peak gradient of 30mmhg.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: 8453098
• MDR Text Key: 139887375
• Report Number: 2025587-2019-01037
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P870078
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HA24227H
• Device Catalogue Number: HA24227H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 129