MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS REDUCED AORTIC VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	R5-021
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, a carbomedics reduced prosthesis model r5-021 was intended for an aortic valve replacement.It is reported that during the suturing procedure, it was noticed that one leaflet had been broken and fell from the hinge.Prior to suturing the valve no device nor leaflet malfunctions were noted.Ultimately, the patient received a carbomedics standard model a5-021.The patient was not adversely impacted by the event and was discharged.
Additional Manufacturer Narrative
The device involved in the complaint was returned to the manufacturer and it was received on (b)(6) 2020.Further investigation is ongoing.
Additional Manufacturer Narrative
Updated fields: b4, g4, g7, h1, h2, h6.After decontamination, the visual inspection revealed marks of suture stitches on the cuff, consistent with the suture procedure as per description received from the field.The broken leaflet corresponds to the right leaflet that results fractured in 4 fragments.On the broken leaflet is possible to identify the locations of the fracture origins.Several traces of contact with surgical tools, detected on the internal surface of the orifice and on the outflow side of the leaflet still in position.Examination of the fracture surfaces at varying magnifications confirmed the absence from harmful voids, inclusions or other manufacturing/ material related defects, which would have contributed to the fracturing of the leaflet.Review of the data contained in the device history record confirmed that the returned carbomedics valve sn (b)(6) satisfied all material and dimensional requirements of a carbomedics reduced - model r5-021, at the time of manufacture and release.The examination of the returned carbomedics valve led to the conclusion that a load, exceeding the ultimate strength of the pyrolytic carbon, was inadvertently applied to the leaflet during the handling of the device for implantation, causing local over loading and torque of the component and finally resulting in the leaflet breakage and escaping.Typical example of possible simulated mishandling causing at once a bending of the leaflet and an over-rotation of the leaflet respect one of the pivots that are the physical stop of the normal rotation are documented, and it results in an overload on the leaflet in correspondence to the outflow pivot.Based on the investigation performed, the root cause of the reported event can be attributed to use error.

• Brand Name: CARBOMEDICS REDUCED AORTIC VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10423174
• Report Number: 3005687633-2020-00130
• Device Sequence Number: 19827167
• Product Code: LWQ
• UDI-Device Identifier: 08022057012777
• UDI-Public: (01)08022057012777(240)R5-021(17)240512
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2024
• Device Model Number: R5-021
• Device Catalogue Number: R5-021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 08/10/2020; 09/15/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/08/2020; 10/14/2020
• 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
• Patient Age: 51 YR
• Patient Weight: 77