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

Model Number	HC150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pulmonary Valve Stenosis (2024)
Date of Event	04/04/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return of the product, no definitive conclusion can be made regarding the clinical observation.
Event or Problem Description
Medtronic received information that 1 year 7 months post implant of this 12mm pulmonary bioprosthetic valved conduit in a pediatric patient, the device was explanted and replaced with a non-medtronic 16mm pulmonary valved conduit due to severe pulmonary stenosis.During the procedure, the physician performed a vsd closure and bifurcation plasty.No other 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: 6917271
• Report Number: 2025587-2017-01767
• Device Sequence Number: 16453667
• Product Code: LWR
• UDI-Device Identifier: 00681490908726
• UDI-Public: 00681490908726
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P790007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2010
• Device Model Number: HC150
• Device Catalogue Number: HC150-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 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: 27 MO
• Patient Weight: 19