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

Model Number HA25019HD

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 06/20/2002

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Facility in section e has not been confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that seven months post implant of this pulmonary valved conduit in a (b)(6) patient, cardiac catheterization revealed mild stenosis.Three years and eight months post implant, the 19mm conduit was explanted and replaced with a 21mm non-medtronic valve due to severe regurgitation.The patient's right ventricular outflow tract was also reconstructed at this time with a non-medtronic graft.No additional adverse patient effects were reported. .

• Brand Name: HANCOCK
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISON; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISON; 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: 8392146
• MDR Text Key: 137878451
• Report Number: 2025587-2019-00819
• Device Sequence Number: 1
• Product Code: LWR
• 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: company representative,health
• 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: 06/19/1999
• Device Model Number: HA25019HD
• Device Catalogue Number: HA25019HD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2019
• Date Device Manufactured: 06/19/1996
• 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: 4 YR