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

Model Number PVC216

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arrhythmia (1721); Heart Failure (2206)

Event Date 08/29/2013

Event Type  Injury  

Manufacturer Narrative

The device remains implanted and will not be returned for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.The device serial number was not reported.Without the serial number, the device manufacturing date and expiration date may not be obtained.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.

Event Description

Medtronic received information that on the day of implant of this pulmonic bioprosthetic valved conduit, the patient developed heart failure and an arrhythmia immediately after the procedure.The patient was treated with an extracorporeal membrane oxygenation (ecmo) and medication.Subsequently, the patient was implanted with a permanent pacemaker due to sick sinus syndrome six weeks after the valve implant.

Manufacturer Narrative

Additional information received indicated that the device did not cause or contribute to the need for the permanent pacemaker implant.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

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.

• Brand Name: VALVE 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: 6189117
• MDR Text Key: 62836526
• Report Number: 2025587-2016-02049
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2017
• Device Model Number: PVC216
• Device Catalogue Number: CONTEGRA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2013
• 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