MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number CPHV

Device Problems Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 07/20/2020

Event Type  Injury  

Event Description

Received the following information from patient tracking department indicating the following in the patient registration form: a carbomedics top hat valve s5-021 was implanted on (b)(6) 2017 and explanted on (b)(6) 2020.No further information is provided at this time.The manufacturer has not received any allegation of a device malfunction 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.Since the device was reported as not available for return, no further investigation is possible at this time.Based on the available information, the root cause of the reported early explant cannot be reasonably attributed to a device deficiency.The device functionality was checked, both prior to the re-do surgery and at the time of explant, and a proper functionality was confirmed.Based on the medical judgment received, it is possible that the mitral valve may have been impinging upon the aortic valve thus resulting in the increase of the gradient detected.Furthermore, since the patient was living overseas and there was an unknown history of inr management, it is possible that a poor management of the anticoagulation therapy contributed to this event.The manufacturer is reporting this event in a conservative way due to the early re-intervention with a mechanical valve.However, based on the information collected and investigation performed, the root cause can be reasonably linked to the patient's specific conditions/factors.Should any further information become available, the manufacturer will re-open and properly re-assess the case.

Event Description

Received the following information from patient tracking department indicating the following in the patient registration form: a carbomedics top hat valve s5-021 was implanted on (b)(6) 2017 and explanted on (b)(6) 2020.The manufacturer has not received any allegation of a device malfunction from the site regarding this event.Per additional information received, this was a young patient who received an avr and mvr for rheumatic heart disease.The patient was living overseas and there was an unknown history of inr management, there was a progressive increase in the aortic valve gradient however on echo the leaflets appeared to be mobile.The 21mm valve was explanted having been seen to be functional with a concern that the mitral valve may have been impinging upon the aortic valve.It was possible to up size to a 23mm valve with the position of the new implant rotated to avoid any further potential mitral valve impact.It was confirmed that no device malfunctions were identified and that the patient has done well after the procedure.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strtada crescentino snc; saluggia, vercelli
• MDR Report Key: 10731069
• MDR Text Key: 213014355
• Report Number: 1718850-2020-01176
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)210415
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/29/2020,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2020
• Device Age: 50 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR