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

Model Number	HC15022
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pulmonary Insufficiency (2022); Pulmonary Valve Stenosis (2024); No Information (3190)
Date of Event	03/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9968799
• Report Number: 2025587-2020-01296
• Device Sequence Number: 14220714
• Product Code: LWR
• UDI-Device Identifier: 00681490908818
• UDI-Public: 00681490908818
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: HC15022
• Device Catalogue Number: HC15022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR