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

Model Number CPHV

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Endocarditis (1834); No Information (3190)

Event Date 11/10/2019

Event Type  Injury  

Manufacturer Narrative

Disposition unknown.

Event Description

The manufacturer was informed about a carbomedics standard heart valve, model # a5-029, serial # (b)(4) that was implanted on (b)(6) 2018.The device was eventually explanted and replaced with another device carboseal valsalva valve cp-027 on (b)(6) 2019.No other information was provided to-date.

Manufacturer Narrative

The manufacturer received additional information from the site identifying the following.The re-do procedure was a result of endocarditis.No device malfunctions were identified.After the procedure the patient was discharged normally.The operational report was received and the procedural details are as follows.A complex and challenging endocarditis case with redo sternotomy, explant of previous permanent pacemaker (ppm), explant of previous mechanical aortic valve (av), aortic annuluar reconstruction with bovine pericardial patches, mechanical bentall with a 27mm carbomedics valve conduit, placement of two new permanent epicardial leads (right atrium (ra) and right ventricle (rv)) - the previous ppm was removed.Endocarditic material/vegetation was found along lead leading to rv with no complication during removal.The pocket did not appear to be infected but swabs and samples were sent for analysis.Edematous and inflamed aortic root tissue was found.Examination of previous prosthesis demonstrated circumferential dehiscence of valve.The aorto-ventricular junction was entirely disrupted with a large pseudoaneurysm between the aorta and left ventricular outflow tract (lvot) where the annulus would be.This made the anatomy difficult to identify.The valve was essentially floating in the lvot.The valve and associated sutures and pledgets were removed easily as they were not anchored into annulus.Significant endocarditic material and vegetation along lvot going into myocardium.No issues with the mv.Aggressive debridement was performed.Site elected to proceed with root replacement given the extent of debridement and patched 2/3rds the lvot / annulus / and myocardium from non-coronary cusp and left coronary cusp.Following patching, 16 pledgeted sutures placed on "aortic" side; sized for a 27mm carbomedics valve conduit.No major issues with bentall procedure.Patient was slowly weaned from cardiopulmonary bypass on first attempt with no issues.Patient was coagulopathic.Epicardial wires were placed for future ppm.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 information available the site indicated no device malfunctions.In addition, given the document review performed, which included a review of the sterility process, no manufacturing deficits were identified.Considering the rigorous sterilization process that each livanova device undergoes at the time of manufacture, verified during the document review, it is unlikely that the endocarditis was caused by the device.This is further supported by the duration from implant to the time of infection.Further details received in the operational report indicated vegetation along the patients pacing wire indicating a potential relationship between the ppm and the patients endocarditis.Given these pieces of information there is no reasonable evidence suggesting a relationship between the device and the endocarditis.At this time no further investigations will be performed and the case will be closed as not device related.The event conclusion is thus cause cannot be traced to device : adverse event related to patient condition.Fields changed: b4, b5, g4, g7, h2, h6.

• 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: 10112320
• MDR Text Key: 193617265
• Report Number: 3005687633-2020-00125
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012654
• UDI-Public: (01)08022057012654(240)A5-029(17)210520
• 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
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: CPHV
• Device Catalogue Number: A5-029
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention