MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(6) 2022, during the implanting procedure of a carbomedics standard aortic mechanical heart valve, a5-019, the damage of the valve sewing rings ¿ slit was noted which resulted in failure of the sutures of the valve and which threatened the life of the patient.Thereafter, a new valve was implanted in the patient.Based on the medical judgement received, at the beginning of the operation, no unusual thing was noticed with the valve.The problem was noted during the procedure, when the stitches were placed in the sewing ring, so tears are caused during the passage of the stitches through the sewing ring.Then, it was decided to use another valve and procedure was performed successfully and the patient was released from the hospital.
Additional Manufacturer Narrative
The device was returned to the manufacturer.During the visual inspection performed after the formalin treatment, the distortion between the holder and the device and the tension on the green threads between the holder and the fabric of the cuff are clear.The holder appears partially outside the device itself reasonably due to an overload applied on the holder tip and the prosthesis.The visual inspection conducted by means of the microscope, was focused principally to ''slit'' observed on the cuff, but also to the alteration detected on the tip of the holder.The mentioned slit on the cuff is due to the separation of two portion of the cuff that by design are joined by a stitching line which appears interrupted.Further enlargements, documenting the morphology of each end, clearly show that the thread has been cut.It is not possible to identify with certainty the cause of this clean cut, but it is reasonable to relate it to the use of surgical instruments (i.E., scissors or scalpels) or, more likely, the use of sharp needles.With regard to the partial exit of the holder from the valve, it can be highlighted that several imprints have been identified both inside and outside the tip of the holder.These traces are undoubtedly attributable to the use of surgical instruments (i.E., klemmer pliers, hemostatic forceps etc.), but the reason why it was necessary to apply such a force as to favor their displacement remains unclear.Nonetheless, it can be considered irrelevant to the root cause of the alteration claimed and observed on the cuff.Based on the analysis performed, the reported event cannot be explained by any factor intrinsic in the involved device.The inspections performed on the returned valve confirmed the absence of manufacturing defects.The separation of the two portions of fabric is due to the interruption of the stitching line which, by design, unites them.The morphology of both ends of the thread is clearly related to a clean cut.As such, the most probable cause of this cut can be reasonably related to the use of surgical instruments or, more likely, the use of sharp needles.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 15642901
• Report Number: 3005687633-2022-00140
• Device Sequence Number: 12232897
• Product Code: LWQ
• UDI-Device Identifier: 08022057012609
• UDI-Public: (01)08022057012609(240)A5-019(17)250925
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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 Expiration Date: 09/25/2025
• Device Model Number: CPHV
• Device Catalogue Number: A5-019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown