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

Model Number	HC15020
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Endocarditis (1834); Pulmonary Insufficiency (2022); Pulmonary Valve Stenosis (2024); No Information (3190)
Date of Event	08/18/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned.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 14 years and 9 months post implant of this 20mm pulmonary valved conduit in a (b)(6) pediatric patient, it was replaced valve-in-valve with a transcatheter bioprosthetic pulmonary valve.The reason for replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received information that this 20mm pulmonary valved conduit was implanted due to tetralogy of fallot and pulmonary atresia.Five years post implant, a 31mm cryolife pulmonary homograft was placed.Ten years following the homograft placement, a bare metal stent angioplasty was performed for moderate stenosis with moderate calcification and mild insufficiency.Four months following the implant of the bare metal stent, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted.Four years following the tpbv implant, the patient was successfully treated for endocarditis with six weeks of antibiotic therapy.No additional adverse patient effects are reported.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9207685
• Report Number: 2025587-2019-03184
• Device Sequence Number: 2950692
• Product Code: LWR
• UDI-Device Identifier: 00681490908795
• UDI-Public: 00681490908795
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P790007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2019

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
• Operator of Device: Health Professional
• Device Model Number: HC15020
• Device Catalogue Number: HC15020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 12/04/2019; 12/04/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/30/2019; 12/30/2019
• 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: 21 YR
• Patient Weight: 66