MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L CARBOMEDICS REDUCED AORTIC VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number R5-019

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

The complete manufacturing and material records for the carbomedics reduced aortic valve, model # r5-019, s/n (b)(4), were retrieved and reviewed by quality control at livanova.The results confirmed that this valve satisfied all material, visual, and performance standards required for a carbomedics reduced aortic valve, model # r5-019 at the time of manufacture and release.Further information has been requested from the physician by the manufacturer.Based on limited information received the root cause cannot yet be determined at this time.The device is not available for return or analysis.Not available for return.

Event Description

On (b)(6) 2017 the manufacturer was notified through patient tracking of a carbomedics reduced aortic valve size 19 that was explanted on (b)(6) 2017 after 7.84 implant duration.The device was previously implanted on (b)(6) 2010.No further information will be provided to the manufacturer on this event.

• Brand Name: CARBOMEDICS REDUCED AORTIC VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada crescentino snc; saluggia,, vc 13040 ; CA 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia,, vc 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 7069644
• MDR Text Key: 93286453
• Report Number: 3005687633-2017-00120
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900060
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/14/2013
• Device Model Number: R5-019
• Device Catalogue Number: R5-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR