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 Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/17/2019

Event Type  Death  

Manufacturer Narrative

Device location not presently known.

Event Description

On (b)(6) 2019, a top hat size 19 was reportedly implanted/explanted on the same day.Based on the information reported, the patient passed away on the same day.No other information is available at this time.

Event Description

On (b)(6) 2019, a top hat size 19 was reportedly implanted/explanted on the same day.The device did not fit in the patient's annulus and a freestyle root was ultimately implanted in the patient.There was no perceived issue with the explanted top hat and the event was attributed to the patient's small annulus.The patient passed away on the same day, but per the surgeon's assessment, the device was not suspected to be a contributory cause.

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 site's assessment, the device explant occurred due to mis-sizing due to the patient's small annulus.As such, the root cause of the adverse event is deemed to be related to patient's factors and not to the device.Regarding the patient's death, it was confirmed that it occurred after the top hat explant and it was deemed not device-related.

• 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: 8791469
• MDR Text Key: 151094280
• Report Number: 3005687633-2019-00215
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012890
• UDI-Public: (01)08022057012890(240)S5-019(17)210516
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2021
• Device Model Number: S5-019
• Device Catalogue Number: S5-019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 73 YR