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

Model Number PVC200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that four years, eight months post implant of this bioprosthetic pulmonic valve in a pediatric patient, angiography showed severe conduit and moderate proximal branch pulmonary artery (pa) stenosis with systemic right ventricle (rv) pressure.The rv-pa conduit had multiple stents from previous catheterizations due to conduit stenosis.The device was replaced and no further adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this device replacement was necessitated by patient outgrowth, and not due to a product problem.The physician's practice confirmed that the device will not be returned for analysis.Patient weight added.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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: 6155836
• MDR Text Key: 61809528
• Report Number: 2025587-2016-01963
• Device Sequence Number: 1
• Product Code: MWH
• 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,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2013
• Device Model Number: PVC200
• Device Catalogue Number: 200H12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2011
• 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: 5 YR
• Patient Weight: 19