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

Model Number	S5-019
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/17/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device location not presently known.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8791469
• Report Number: 3005687633-2019-00215
• Device Sequence Number: 11231910
• Product Code: LWQ
• UDI-Device Identifier: 08022057012890
• UDI-Public: (01)08022057012890(240)S5-019(17)210516
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 73 YR