MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS REDUCED AORTIC VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number R5-019

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

Unknown disposition.

Event Description

The manufacturer was informed on this event through the device tracking department.Based on the information reported on the patient implant form, a carbomedics reduced mechanical valve r5-019 was implanted on (b)(6) 2014 and explanted on (b)(6) 2020.No further information is presently available.No indication of a device malfunction nor serious injury was received from the site regarding this event.

Manufacturer Narrative

A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.The manufacturer made several attempts to follow-up for further information on the event and on the device disposition, however, at this time no further information has been received.Based on the available information, it is not possible to draw a definitive conclusion to the reported event.However, from the document review performed, no manufacturing deficits were identified.At this time because no further information is available and the device is not available for analysis the root cause cannot be established.Should further information be received, the manufacturer will reassess the investigation and provide an update to this reporting activity.

• Brand Name: CARBOMEDICS REDUCED AORTIC VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10805554
• MDR Text Key: 215287402
• Report Number: 3005687633-2020-00148
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012760
• UDI-Public: (01)08022057012760(240)R5-019(17)181210
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2018
• Device Model Number: R5-019
• Device Catalogue Number: R5-019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR