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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBO-SEAL ASCENDIC AORTIC PROSTHESIS; HEART VALVE, MECHANICAL
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SORIN GROUP ITALIA S.R.L. CARBO-SEAL ASCENDIC AORTIC PROSTHESIS; HEART VALVE, MECHANICAL Back to Search Results
Model Number AP-023
Device Problem Difficult to Open or Close (2921)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 07/05/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: device location not presently known.
 
Event Description
A carbomedics carbo seal ap-023 conduit valve was implanted in a patient as part of a bentall procedure (aortic root replacement with hemiarch).After the implantation, the surgeon faced technical issues in the "swing ring" and concerns were raised on the leaflet motion of the implanted valve.Immediately the valve was explanted and another carboseal ap-021 ((b)(4)) was implanted to the patient.The change of sizing was due to unavailability of the same size or a bigger size (i.E.Ap-023, 25) in operation theatre.The date of the event is presently unknown.
 
Manufacturer Narrative
The device was returned to the manufacturer and it was received on 06 nov 2019.The device was received inside a carton box quite damaged, but with the blister was in undamaged conditions.The carboseal was it the blister opened, it was mounted on the holder/manipulator and appered in generally good conditions except some traces of blood.Further investigation is ongoing.
 
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.
 
Event Description
A carbomedics carbo seal ap-023 conduit valve was implanted in a patient as part of a bentall procedure (aortic root replacement with hemiarch).After the implantation, the surgeon faced technical issues in the "swing ring" and concerns were raised on the leaflet motion of the implanted valve.Specifically, it is reported that the leaflets were opening partially and there seemed to be a hindrance to the free movement of the complete opening of valve leaflets.Immediately the valve was explanted and another carboseal ap-021 (s1309258-b) was implanted to the patient.The patient remained stable during the procedure and a good outcome is reported.The change of sizing was due to unavailability of the same size or a bigger size (i.E.Ap-023, 25) in operation theatre.The date of the event is presently unknown.
 
Event Description
On (b)(6) 2019, a carbomedics carbo seal ap-023 conduit valve was implanted in a patient as part of a bentall procedure (aortic root replacement with hemiarch).During the implantation, the surgeon faced technical issues in the "swing ring" and concerns were raised on the leaflet motion of the implanted valve.Specifically, it is reported that the leaflets were opening partially and there seemed to be a hindrance to the free movement of the complete opening of valve leaflets.This issue was detected when the surgeon was checking the leaflet motion and rotation of the valve, before the closure of the aorta.Immediately the valve was explanted and another carboseal ap-021 (s1309258-b) was implanted to the patient.The patient remained stable during the procedure and a good outcome is reported.The change of sizing was due to unavailability of the same size or a bigger size (i.E.Ap-023, 25) in operation theatre.
 
Manufacturer Narrative
The device investigation has been completed.The fabric related to the vascular portion appeared rigid as per water soaking and subsequent dried.The visual inspection performed on the returned prosthesis confirmed the absence of pre-existing manufacturing defects, in particular, it was possible to verify the complete closure of the leaflets.As the device was received in a clean and reassembled state, it was not possible to conduct a thorough analysis the returning conditions of the device altered the scenario reported in the case history and can no longer be considered representative of the event detected by the customer.However, based on the investigations performed, the problem experienced by the customer cannot be explained by any factor intrinsic and / or pre-existing defects found in the involved device.
 
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Brand Name
CARBO-SEAL ASCENDIC AORTIC PROSTHESIS
Type of Device
HEART VALVE, MECHANICAL
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada crescentino snc
saluggia, vercelli
MDR Report Key8848938
MDR Text Key152908538
Report Number3005687633-2019-00219
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
PMA/PMN Number
P900060
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2022
Device Model NumberAP-023
Device Catalogue NumberAP-023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2019
Was the Report Sent to FDA? No
Date Manufacturer Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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