MAUDE Adverse Event Report: CORCYM SRL CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, a carbomedics standard mitral valve m7-027 was intended to be implanted.During the procedure, the physician opened the valve product and used the tester, then they found one of the leaflets could not be opened after the knot.The valve was replaced with another product.The patient was reportedly not affected by the event.
Event or Problem Description
On (b)(6) 2021, a carbomedics standard mitral valve m7-027 was intended to be implanted.During the procedure, the physician opened the valve product and used the tester, then they found one of the leaflets cannot be opened after the knot (i.E suturing).The patient is reportedly not affected by the event.Per additional information received, it was confirmed that the leaflet dysfunction was identified after the suturing was completed.The surgical approach used was suture everting, and resection of the native mitral valve (leaflets, chordae and papillary muscles).The leaflets were tested with the dedicated tester.The device was ultimately replaced with a carbomedics standard mitral valve m7-25.It was clarified also that the patient remained stable and the outcome was good, no impact on patient.Furthermore, it was reported that there is no abnormal found at the echo for the first implanting cphv valve.
Additional Manufacturer Narrative
The returned valve prosthesis appears in general good storage conditions, with slight blood traces.Marks of suturing procedure are visible.The leaflets were able to move from the totally closed to the open position.After the formalin and the hypochlorite treatment, the visual inspections performed on the returned valve confirmed the absence of manufacturing defects.The sewing cuff was then removed, and further cleaning process has been performed.The serial number etched on the orifice is congruent with the one indicated from the field (i.E.Subassembly 1481585).The hydrodynamic testing conducted on the cphv subassembly #27 of the valve m7-027 ¿ sn s1481585-a was performed using the r0706 - vivitro pulse duplicator equipment.The valve showed a correct movement of the leaflets during opening and closure phases.No anomalies were observed both in hypotensive and in normotensive conditions.Furthermore, 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.Based on the investigations performed, the subject prosthesis was characterized by regular mechanical, kinematic and hydrodynamic behavior as determined by means of hydrodynamic tests performed on the returned valve.As such, the reported event of leaflet immobilization cannot be attributed to any abnormal features of the explanted prosthesis.Phenomena of partial leaflet immobilization that could induce an opening/closing difficulty in a mechanical valve prosthesis have been described in the clinical literature.Possible causes for this type of events are identified in: entrapment between the leaflets and the housing of unravelled sutures, long suture ends or strands of chordal tissue, prosthesis size mismatch, suboptimal valve orientation, peculiar hydraulic conditions in the heart.Based on the investigations performed and information reported, confirming that the patient ultimately received a prosthesis of the same model but of a smaller size, the most reasonable root cause could be attributed to a prosthesis size mismatch.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11881682
• Report Number: 3005687633-2021-00124
• Device Sequence Number: 19683158
• Product Code: LWQ
• UDI-Device Identifier: 08022057012722
• UDI-Public: (01)08022057012722(240)M7-027(17)250418
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2025
• Device Model Number: CPHV
• Device Catalogue Number: M7-027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention