MAUDE Adverse Event Report: HEART VALVES SANTA ANA CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number 200H

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335); No Information (3190)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that three years, two months post implant of this bioprosthetic pulmonic valve in a pediatric patient, this device was replaced valve-in-valve with a transcatheter pulmonic valve.No failure mechanism and no other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this device was replaced valve-in-valve due to significant calcification, with moderate insufficiency and conduit stenosis.Prior to the replacement, the patient presented with moderate tricuspid regurgitation, and moderate blood vessel dilation downstream from valve.No complications were mentioned in the patient's notes resulting from the replacement procedure.No other adverse patient effects were reported.Patient weight added.Patient's relevant medical history added.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 6616602
• MDR Text Key: 76817573
• Report Number: 2025587-2017-00918
• Device Sequence Number: 1
• Product Code: MWH
• UDI-Device Identifier: 00613994600349
• UDI-Public: 00613994600349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020003
• 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,Followup,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2014
• Device Model Number: 200H
• Device Catalogue Number: 200H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2011
• 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: 14 YR
• Patient Weight: 75