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

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown disposition.
Event or Problem Description
The manufacturer was informed of this event through the patient tracking department.Based on the information reported in the patient implant form, a carbomedics top hat valve s5-025 was implanted on (b)(6) 2021.This valve was explanted on (b)(6) 2021 and replaced with a carbomedics top hat valve s5-027.The manufacturer was also informed that the patient passed away on the same day after the implant of s5-027.(reported separately under ln (b)(4).No further information is presently available.No allegation of a device malfunction nor of a serious injury was indicated during this particular event.
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.The manufacturer attempted to retrieve additional information on the reported event and the device involved.Since no further information was received and the device was not returned after the explant (unknown disposition), no further investigation is possible at this time.Based on the available information, it is not possible to draw a definitive conclusion to the reported event.However, per the document review performed, no manufacturing deficiencies were identified for the involved device.The root cause remains undetermined at this time.Should further information be received in the future, a follow up report will be submitted.
Event or Problem Description
Hold for cr 10/16 the manufacturer was informed of this event through the patient tracking department.Based on the information reported in the patient implant form, a carbomedics top hat valve s5-025 was implanted on (b)(6) 2021.This valve was explanted on (b)(6) 2021 and replaced with a carbomedics top hat valve s5-027.The manufacturer was also informed that the patient passed away on the same day after the implant of s5-027 (submitted separately under (b)(6)).No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 11895130
• Report Number: 3005687633-2021-00131
• Device Sequence Number: 3160927
• Product Code: LWQ
• UDI-Device Identifier: 08022057012920
• UDI-Public: (01)08022057012920(240)S5-025(17)220822
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: 08/22/2022
• Device Model Number: CPHV
• Device Catalogue Number: S5-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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: Required Intervention
• Patient Age: 54 YR