MAUDE Adverse Event Report: HEART VALVES SANTA ANA HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	HC150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The available information indicates the device remains implanted.Additional information has been requested regarding the device's functionality, any adverse patient effects and the patient's weight.A supplemental report will be filed if additional information is received and/or when investigation is completed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that approximately fifteen years post-implant of this bioprosthetic pulmonic valve in a pediatric patient, this device was replaced valve-in-valve with a transcatheter bioprosthetic valve.No failure mechanism and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this device was replaced with a competitor's valve approximately eleven years post-implant, not fifteen years as was originally reported.Additional information has been requested.No other adverse patient effects were reported.Device explanted date updated.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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6693065
• Report Number: 2025587-2017-01113
• Device Sequence Number: 19025508
• Product Code: LWR
• UDI-Device Identifier: 00681490908818
• UDI-Public: 00681490908818
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P790007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: HC150
• Device Catalogue Number: HC15022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 07/27/2017; 07/27/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 07/27/2017; 10/05/2017
• 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: 23 YR