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

Model Number S5-019

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

Device discarded.

Event Description

On (b)(6) 2005, a female patient received a top hat s5-019 in aortic position.On (b)(6) 2019, the device was explanted and replaced with a reduced r5-023.The top hat was explanted due to growth, identified as vegetation, on the device.The growth reportedly affected both the top hat and the mitral mechanical valve (details not provided).No confirmation on the top hat functionality over time and at the time of the event is available.A good outcome for the patient is reported after the re-do surgery.The patient was under coagulation therapy and no recent changes in the therapy were reported.

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.Based on the available information, it is not possible to determine the root cause of the reported event.However, based on the document review performed, no manufacturing deficits were identified.There was no indication or allegation of a suspected device malfunction contributing to the event.It is possible that the patient's factors contributed to the reported event, although this cannot be ultimately confirmed.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9253240
• MDR Text Key: 172803742
• Report Number: 3005687633-2019-00253
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2009
• Device Model Number: S5-019
• Device Catalogue Number: S5-019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR