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

Model Number R5-021

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

The manufacturer has been notified that a carboseal valsalva device was explanted due to valve malfunction.No further information is presently available, including serial number, device implant/explant dates and patient outcome.

Manufacturer Narrative

A preliminary visual inspection was performed in order to record the gross appearance of the returned material in the ¿as received¿ conditions.The prosthesis was received in a container with a label indicating information that the explant date was (b)(6) 2020 and that the implant occurred in 2001.Assuming in a conservative manner the device was implanted in december of 2001 this information allows an estimated implantation time of approximately 18.8 years.The complete dhr, filed by the quality control department, was retrieved, and reviewed in order to verify all manufacturing and quality control steps.The result of the device history record review of the returned cphv prosthesis sn (b)(6) confirmed that the returned product satisfied all material, dimensional and performance standards, required for a carbomedics reduced aortic r5-021 at the time of manufacture and release, including the function test of the valve in a hydrodynamic tester, performed on march 23, 2001.As per preliminary inspection, the returned prosthesis was missing of the conduit component and after a more careful review it was confirmed not to be a carboseal valsalva but rather an aortic valve, carbomedics reduced r5-021.The visual examination revealed significant fibrous pannus on the outflow side of sewing ring slightly protruding into the lumen forming a narrowing of the opening.Other small fibrous pannus depositions were present on the inflow side of sewing ring.A small fabric tube, almost completely incorporated in the pannus, was visible on the sewing ring.The movement of both leaflets was regular.Both sides of both leaflets and both sides of both hinges were normal.After decontamination and the collecting of samples for histological examination, the functional subassembly of the valve was removed, cleaned, and inspected.The serial number of the valve (sn (b)(6) ) has been recovered allowing the correct traceability of the components.The visual inspections performed on the returned valve components confirmed the absence of manufacturing defects.The hydrodynamic testing conducted on the cphv subassembly #21 of the valve r5-021 ¿ sn (b)(6) showed a correct movement of the leaflets during opening and closure phases.No anomalies were observed both in normotensive and in hypotensive conditions.In a mechanical prosthesis, a possible reason of valve malfunction can be associated to leaflet impingement or stenosis correlated to pannus overgrowth reducing the lumen.Considering the lack of information received from the field and the autoptic analysis, it is not possible to exclude the stenosis due to the pannus formation as cause of the valve malfunction.For that reason, a histopathological examination was conducted, in order to verify potential correlation with pathological aspects.The analysis identified red areas due to coagulated blood entrapment were present inside the fibrous pannus and inside the tissue of sewing ring.Yellow areas due to calcifications were present inside the fibrous pannus that covers the outflow side of sewing ring.Small fibrous pannus depositions and thrombus depositions are present on the sewing ring.Gram bacteria were not detected in all samples with the gram stain.Ultimately it is not possible to establish the root cause of the pannus growth.In addition, a dependence on the positioning of the valve on the anatomical site cannot be ruled out.The presence of organic material grown on the inflow side could suggest a smaller valve than the native annular lumen, that could be consistent with the use of the small fabric tube used as filler and finally with a axial position lower than normal with respect to the annular plane.This last aspect can represent a potential cause of pannus overgrowth in the outflow side, that is quite unusual in the aortic prosthesis, causing the observed stenosis.However, based on the limited information available the root cause of the event cannot be determined.The investigation of the device concluded the reported issue is not related to any device related deficiencies or malfunctions associated with the device quality.

Event Description

The event, related to the carbomedics reduced aortic - cphv r5-021 ¿ sn (b)(6) , occurred at the ¿(b)(6) memorial hospital¿ ¿ sunto-gun ¿ japan and it was notified on november 12, 2020 with the following description.The manufacturer has been notified that a carboseal valsalva device was explanted due to valve malfunction.No further information is presently available, including serial number, device implant/explant dates and patient outcome.The manufacturer followed up and was notified that due to covid restrictions no further information could be retrieved.The carbomedics valve was returned to livanova for evaluation.At this time it was detected that the device involved was a carbomedics reduced r5-021 and not a carboseal valsalva as originally indicated.A preliminary visual inspection was performed in order to record the gross appearance of the returned material in the ¿as received¿ conditions.The prosthesis was received in a container with a label indicating information that the explant date was (b)(6) 2020 and that the implant occurred in 2001.Assuming in a conservative manner the device was implanted in december of 2001 this information allows an estimated implantation time of approximately 18.8 years.

• Brand Name: CARBOMEDICS REDUCED PROSTHETIC HEART VALVE, AORTIC
• Type of Device: MECHANICAL HEART VALVE PSROTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10971331
• MDR Text Key: 220448457
• Report Number: 3005687633-2020-00153
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P900060S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2006
• Device Model Number: R5-021
• Device Catalogue Number: R5-021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention