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

Model Number	HC105-20
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024)
Date of Event	06/23/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, approximately 3.5cm of the conduit was returned with a transcatheter valve inside.Several pieces of the conduit were returned loose.Pannus fused the devices together, and was also noted on the inner side of the conduit.Calcification was observed.Due to the return condition of the conduit, the leaflets could not be assessed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that eight years post implant of this bioprosthetic valved conduit, implanted in a (b)(6) year old pediatric patient, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The reason for replacement was reported as moderate to severe stenosis.Six years and nine months post valve-in-valve, both products were explanted and replaced with another bioprosthetic valved 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: 7508889
• Report Number: 2025587-2018-01115
• Device Sequence Number: 11053819
• Product Code: LWR
• UDI-Device Identifier: 00681490908597
• UDI-Public: 00681490908597
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P870078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: 07/23/2007
• Device Model Number: HC105-20
• Device Catalogue Number: HC105-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/11/2018
• 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: 17 YR