MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS27

Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pleural Effusion (2010); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

A patient received a perceval xl aortic valve due to severe aortic valve stenosis.An extensive decalcification was reported.After the procedure, a paravalvular leak was identified.The patient was decompensated (bilateral large pleural effusions).In the transthoracic echo, there were 2 jets - one originating from the lvot/basal septum into the right atrium and one toward the right ventricle with a systolic/diastolic flow pattern.In the tee study, it was verified that there are 2 jets originating from the sinus of valsalva (basically corresponding to the tte study).As reported by the physician, the patient may not decompensate because of the jet.

Event Description

A patient received a perceval xl aortic valve due to severe aortic valve stenosis on (b)(6) 2021.An extensive decalcification was reported.On (b)(6) 2021, a paravalvular leak was identified.The patient was decompensated (bilateral large pleural effusions).In the transthoracic echo, there were 2 jets - one originating from the lvot/basal septum into the right atrium and one toward the right ventricle with a systolic/diastolic flow pattern.In the tee study, it was verified that there are 2 jets originating from the sinus of valsalva (basically corresponding to the tte study).As reported by the physician, the patient may not decompensate because of the jet.Additional information was received identifying the following.Regarding the device functionality after the implant, it was confirmed that the device is working.The leakage was already visible but differently interpreted (paravalvular vs tricuspid regurgitation) prior to the postoperative evaluation.As reported, the jets were identified in the tte study performed on (b)(6) 2021, the tee study ((b)(6) 2021) verified the findings.The difference that was found in the tee was that the origin of the jets was truly from the lvot and not the basal septum (which would have been a gerbode defect).Quantification of the 2 leakages was not possible.Overall the flow from the lvot to the ra and rv was present in diastole and systole.Based on the medical judgment received, the leak was defined as not to be hemodynamically relevant as the lv was not dilated and the patient until now is not decompensated (next appointment is in 3 months).The pressure gradients could not be well evaluated.Other causes were not found.As reported, the leakage partially contributed to the state of the patient.Overall the patient's as is repaired, lv function is normal, rv function is normal.The primary cause for the pleural effusions was attributed to be a post thoracotomy syndrome, not the leakage.The patient was discharged on (b)(6) after recompensation with small residual pleural effusions and a minor pulmonary congestion (chest radiograph).Reintervention in case of patients age and the recompensated state with diuretics (spironolacton 50, furosemid 80mg) is not planned (until now).

Manufacturer Narrative

Since the device was not explanted and the serial number is unknown, no further investigation is possible at this time.However, based on the available information and the medical judgment received, there is not enough evidence to suspect a device malfunction which could have caused or contributed to the reported event.The presence of the perivalvular leak, initially reported, was not confirmed at the time of the follow up; on the contrary, the physician confirmed that the perceval valve is working, with no plans for re-intervention.Furthermore, the patient's decompensation (bilateral pleural effusion) was reportedly attributed to be a post thoracotomy syndrome, and was not attributed to the leakage which was assessed as a flow from the lvot to the ra and rv and not hemodynamically significant by the physician.As such, there is no evidence of a serious injury for the patient caused by the device, nor of a device malfunction.Should any further information be received at a later stage, the manufacturer will take further actions as deemed applicable and provide a follow up report as required.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• MDR Report Key: 12045328
• MDR Text Key: 268103505
• Report Number: 3004478276-2021-00176
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• 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: 08/05/2021

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
• Device Operator: Health Professional
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR