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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 CPHV
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, a mitral valve replacement with a carbomedics standard m7-027 was attempted.However, it is reported that when the surgeon implanted the valve, specifically when the sutures have already started to pass through the ring, he detected that the suture ring was not stitched correctly.The device was explanted and replaced with a carbomedics of the same size.The total cross-clamp time was 147 min and the total bypass time was 210 min.The patient remained stable throughout the delay, with no complications.A good outcome is also reported after the surgery.
 
Manufacturer Narrative
The device was returned to the manufacturer and it was received on 19 jun 2019.The sewing cuff of the returned valve appeared damaged in some portions, with few bloodstains.After decontamination, the damages and the stitching marks detected on the sewing cuff were carefully inspected by means of the microscope.The results confirmed that the needle passage occurred too close to the base of the flange of the suture ring.This patter was more evident is specific points of the sewing cuffs.Based on the investigation performed and information received from the field, it is not possible to totally exclude the use of a needle with sharp-edge or with a similar shape (premicron is available in different models of needle tip and it was not confirmed the specific ones used in this event).Furthermore, the complete manufacturing and material records review for the valve m7-027 sn (b)(6) has been performed.The results confirmed that the device satisfied all material, dimensional and performance standards required for a carbomedics standard mitral m7-027 at the time of manufacture and release.Based on the available information and investigation performed, the alterations detected on the cuff surface of the returned valve occurred during the implantation procedure and the damage of the sewing ring cannot be imputed to any pre-existing defects.The root cause of the event can be reasonably attributed to a procedural error, in which the passage of a sharp-edged interrupted and loosened the structural thread of the sewing cuff, ultimately causing the progressive separation of fabric portions.It should be noted that the carbomedics instruction for use (ifu) contains the following warnings to prevent possible damages to the sewing ring during implant: 'apply the sutures to the outer half of the suture ring flange', 'do not use cutting-edge suture needles, which could damage the suture ring'.
 
Event Description
On (b)(6) 2019, a mitral valve replacement with a carbomedics standard m7-027 was attempted.However, it is reported that when the surgeon implanted the valve, specifically when the sutures have already started to pass through the ring, he detected that the suture ring was not stitched correctly (the picture received from the field showed a hole in the sewing cuff).It was reported that some difference in the sewing cuff was noticed also before the implant, although these differences were not further specified, and no evidence was provided.The device was consequently explanted and replaced with a carbomedics of the same size.The total cross-clamp time was 147 min and the total bypass time was 210 min.The patient remained stable throughout the delay, with no complications.A good outcome is also reported after the surgery.It is reported that the sutures/needle used for the procedure were the bbraun premicron 2/0.
 
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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 Key8643118
MDR Text Key146223202
Report Number3005687633-2019-00172
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier08022057012722
UDI-Public(01)08022057012722(240)M7-027(17)231103
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
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/03/2023
Device Model NumberCPHV
Device Catalogue NumberM7-027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Was the Report Sent to FDA? No
Date Manufacturer Received06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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