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

Model Number PVC200S

Device Problem Biocompatibility (2886)

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

Event Date 06/06/2016

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 six years and three months post implant of this pulmonary valved conduit in a pediatric patient, it was explanted and replaced due to stenosis and calcification.No further adverse patient effects were reported.

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: 5773941
• MDR Text Key: 48917286
• Report Number: 2025587-2016-00989
• 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
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2012
• Device Model Number: PVC200S
• Device Catalogue Number: 200SH14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2009
• 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: 7 YR
• Patient Weight: 48