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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS
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SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS Back to Search Results
Model Number M7-025
Device Problems Fracture (1260); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, a carbomedics standard mitral m7-025 was intended for a mitral valve replacement.During the implantation, the valve was reportedly "tight" and a valve leaflet fell off during the adjustment.A new valve of the same model was immediately replaced.The procedure was successfully completed with the new m7-025 and the patient had a good outcome after surgery.No perceived issues with the device were reported before the implant.
 
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.Further investigation is ongoing.
 
Event Description
On (b)(6) 2019, a carbomedics standard mitral m7-025 was intended for a mitral valve replacement.During the implantation, it was reported that one of the leaflets did not move smoothly, and reportedly 'got stuck' somehow.It was attempted to adjust it, but then the leaflet fell off during adjustment.A new valve of the same model was immediately replaced.The procedure was successfully completed with the new m7-025 and the patient had a good outcome after surgery.No perceived issues with the device were reported before the implant.
 
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.Further investigation is ongoing.
 
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Brand Name
CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
Type of Device
MECHANICAL HEART VALVE PROSTHESIS
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada crescentino snc
saluggia, vercelli
MDR Report Key9392073
MDR Text Key168781842
Report Number1718850-2019-01191
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier08022057012715
UDI-Public(01)08022057012715(240)M7-025(17)230224
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup,Followup,Followup
Report Date 11/04/2019,01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/24/2023
Device Model NumberM7-025
Device Catalogue NumberM7-025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/04/2019
Device Age19 MO
Event Location Hospital
Date Report to Manufacturer11/04/2019
Date Manufacturer Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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