MAUDE Adverse Event Report: PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS21

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

Unknown device disposition.

Event Description

On (b)(6) 2021, a perceval valve pvs21 was indwelled after cabg (three vessels).The perceval valve did not fit the annulus due to the narrow annulus and valsalva, and pvl occurred (mild), so the valve was explanted.After expanding the annulus, trifecta 19 mm was indwelled but it was further removed since it did not work.Inspiris 19 mm was indwelled instead and the procedure was completed.

Event Description

On (b)(6) 2021, a perceval valve pvs21 was indwelled after cabg (three vessels).The perceval valve did not fit the annulus due to the narrow annulus and valsalva, and pvl occurred (mild), so the valve was explanted.After expanding the annulus, trifecta 19 mm was indwelled but it was further removed since it did not work.Inspiris19mm was indwelled instead and the procedure was completed.Based on the additional information provided, the device oversizing was the cause of the perivalvular leak noted (pvl).No stent folding nor mispositioning occurred.Based on the surgeon's assessment, there was probably no relation between the device and event.No device malfunction was observed in visual confirmation regarding the explanted device.The patient remained stable during procedure and there was no problem after the surgery.The patient was discharged from the hospital.

Manufacturer Narrative

Fields updated: b4, b5, g3, g6, h1, h2, h6.The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(6), and its nitinol stent component, as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Since the device was reportedly not available for return, no further device investigation was possible.Based on the information available, the root cause of the reported event can be traced to a device mis-sizing (use error).No device malfunctions were identified based on the information received from the field, and there was no patient's adverse consequences as a result of the event.Furthermore, the surgeon excluded any direct relationship between the event and the device.As such, no further investigation is warranted at this time.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• MDR Report Key: 12537478
• MDR Text Key: 273550781
• Report Number: 3004478276-2021-00256
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)240305
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2024
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 31