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

Model Number 200SH

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problems Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: 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 5 years 8 months post implant of this pulmonary bioprosthetic valved conduit in this pediatric patient, the device was replaced valve-in-valve with a transcatheter pulmonary valve (tpv) due to severe symptomatic conduit stenosis.The valve appeared heavily calcified with severe stenosis ¿ peak gradient of 90 mm hg by echocardiogram.By catheter it was noted to be 50 mm hg gradient across the conduit with an rv pressure of 70 mm hg (80% systemic).No additional adverse patient effects were reported.

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• 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: 7138013
• MDR Text Key: 95488796
• Report Number: 2025587-2017-02522
• 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
• Report Date: 12/21/2017

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: 12/12/2013
• 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: 11/29/2017
• Initial Date FDA Received: 12/21/2017
• Date Device Manufactured: 01/27/2010
• 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: 10 YR
• Patient Weight: 33