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

Model Number	HC15020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pulmonary Regurgitation (2023)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Medtronic received information that 7 years post implant of this 20 mm pulmonary valved conduit in a (b)(6)-month-old pediatric patient, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The valve was replaced due to severe regurgitation.Of note, it was reported that when the conduit was originally implanted, the surgeon removed the steel supporting ring from the conduit.No additional adverse patient effects were reported. .

• 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: 10662477
• Report Number: 2025587-2020-03085
• Device Sequence Number: 19714975
• Product Code: LWR
• UDI-Device Identifier: 00681490908795
• UDI-Public: 00681490908795
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P790007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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 Expiration Date: 05/04/2017
• Device Model Number: HC15020
• Device Catalogue Number: HC15020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/12/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 9 YR