• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORIN GROUP ITALIA SRL CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART VALVE, MECHANICAL Back to Search Results
Model Number TBD
Device Problem Difficult to Open or Close (2921)
Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834)
Event Type  Injury  
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 april 2020 was 27mmhg.In the past the patient was already affected by endocarditis that finally was solved.
 
Manufacturer Narrative
Fields updated: b4, g3, g9, h1, h2 (indicated as a placeholder, no new information received), h6.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.
 
Event Description
See initial report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11646329
MDR Text Key252090705
Report Number1718850-2021-01053
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 07/19/2021
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
Device Operator Health Professional
Device Model NumberTBD
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/06/2021
Event Location Hospital
Date Report to Manufacturer07/19/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/09/2021
Supplement Dates Manufacturer Received07/19/2021
Supplement Dates FDA Received07/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age70 YR
Patient Weight90
-
-