MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART VALVE, MECHANICAL

Model Number TBD

Device Problem Difficult to Open or Close (2921)

Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

The manufacturer was informed that a patient with a carboseal device #23/26 (exact model not reported) underwent a follow up transesofageal echo and fluoroscopy for a suspected endocarditis.The echo showed a pressure gradient of 30mmhg and suspected hypomobility of the leaflet.The pressure gradient in (b)(6) 2020 was 27mmhg.In the past the patient was already affected by endocarditis that finally was solved.

Manufacturer Narrative

The manufacturer attempted to retrieve additional information on the event and the device involved, but no further information has been received to date.Since the device was not returned for investigation (reasonably still implanted) and since the serial number is unknown, no further investigation is possible at this time.Based on the available information, it is not possible to establish a definitive root cause for the reported event.Since endocarditis was suspected, it is possible that the increase of the gradient and the leaflet hypomobility are secondary to this clinical event.However, since the baseline patient's conditions, device functionality over time and final diagnosis and treatment provided are unknown, the root cause cannot be established at this time.Should the manufacturer receive additional information, an update to this reporting activity will be provided.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11646332
• MDR Text Key: 244861354
• Report Number: 3005687633-2021-00112
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P900060/S024
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 90