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

Model Number HC15016

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Valve Stenosis (2024); Right Ventricular Dysfunction (2054)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

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 Description

Medtronic received information that nine years and ten months post implant of this 16mm bioprosthetic pulmonary valved conduit implanted in a (b)(6) patient, it was explanted and replaced with a 20mm conduit of the same model.The conduit was replaced due to severe stenosis and suprasystemic right ventricular pressure.Of note, a "cuff" of the proximal and distal portions of the original graft was retained in the patient.No additional adverse patient effects were reported. .

• Brand Name: HANCOCK
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8391813
• MDR Text Key: 137869858
• Report Number: 2025587-2019-00811
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490908764
• UDI-Public: 00681490908764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2012
• Device Model Number: HC15016
• Device Catalogue Number: HC15016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2019
• Date Device Manufactured: 10/25/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR