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

Model Number CPHV

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  Injury  

Event Description

On (b)(6)) 2020, a carbomedics standard aortic prosthesis model a5-025 was intended for an aortic valve replacement.The manufacturer was informed that the leaflets did not work after the implantation.The event was detected before the aortic closure, thus no functionality of the device at the echo is available.The leaflets were reportedly tested with the dedicated accessories after the implant, with an adequate functionality reported.This resulted in longer bypass and cross clamp time, however the exact delay was not further specified.Another carbomedics standard aortic prosthesis model a5-025 was ultimately implanted.The patient remained stable during the procedure and was discharged uneventfully.

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.After decontamination the inspection with the stereomicroscope was principally focused on the chipped area on the edge of the damaged leaflet.Shiny marks in correspondence to the edge between the fracture and the inflow surface were detected.In general, it is possible to recognize a typical morphology correlated to a contact with surgical tools.After cleaning several traces of needle passage/suture stitches, according with the suture procedure, were observed.Routine quality control examinations included visual inspections, dye penetrant tests, proof-tests, function tests and x-ray inspections designed to detect critical flaws.The inspections performed on the returned valve confirmed the absence of manufacturing defects.The sewing cuff was then removed, in order to identify the serial number, and its position, allowing a correct traceability of the valve and its components.The hydrodynamic testing conducted on the cphv subassembly #25 of the valve a5-025 ¿ sn (b)(6).A was performed to evaluate kinematic behavior.No functional anomalies are observed during the open/close cycles recorded during the kinematic test.The valve showed a correct movement of the leaflets during opening and closure phases.Based on the performed analysis, the reported issue cannot be not related to the device quality.No pre-existing defects were identified in the analysis performed and no functional anomalies were observed during the open/close cycles recorded during the kinematic tests.The results of the analyses lead to the conclusion that the leaflet of the valve was inadvertently damaged during implantation/explantation of the prosthesis by contact with surgical instrumentation, causing chipped surface.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 11181908
• MDR Text Key: 231634329
• Report Number: 3005687633-2021-00097
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: A5-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR