MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number 200SH

Device Problems Calcified (1077); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024); No Information (3190)

Event Date 09/12/2017

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 7 years 1 month post implant of this pulmonary bioprosthetic valved conduit in a pediatric patient, the device was replaced valve-in-valve with a transcatheter pulmonary valve (tpv) for unknown reasons.No additional adverse patient effects were reported. .

Manufacturer Narrative

Additional information received indicated that the device was replaced due to multiple areas of stenosis and calcification of the conduit.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): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES 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: 6936753
• MDR Text Key: 88849797
• Report Number: 2025587-2017-01801
• Device Sequence Number: 1
• Product Code: MWH
• UDI-Device Identifier: 00613994600189
• UDI-Public: 00613994600189
• 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
• Report Date: 11/01/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2013
• Device Model Number: 200SH
• Device Catalogue Number: 200SH18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 10/12/2017
• Supplement Dates FDA Received: 11/01/2017
• Date Device Manufactured: 02/24/2010
• 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: 11 YR
• Patient Weight: 61