MAUDE Adverse Event Report: LIVANOVA CANADA CORP. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVF-S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Ventricular Tachycardia (2132)

Event Date 12/11/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, a perceval plus pvf-s was implanted as part of an aortic valve replacement procedure.On echo, the patient's annulus measured 20mm.The valve preparation and implant went without incident.The device functionality was again tested on (b)(6) 2020, and no issues were detected (no signs of leaking or migration of the device).In the night of (b)(6) 2020 (or early morning or the (b)(6) 2020), the patient had experienced ventricular tachycardia.As reported, there was no chest compression done however, they were cardioverted.They had then been sent to the cath lab and although the cardiologist to access the coronaries, a perceval valve migration was suspected.The patient was brought to the or on (b)(6) 2020 to remove the valve and replace it with another device (size 19mm, magna).The patient got out of the or but the patient had a very weak heart and ended up passing away in the icu about one day after the reoperation.As reported, no concomitant procedure was done at the time of the perceval plus implant, but the patient did have long standing lvh from the chronic aortic stenosis.No oversizing is suspected.

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model pvf-s, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model pvf-s) perceval plus heart valve at the time of manufacture and release.The device was returned to the manufacturer and further testing are undergoing.An update will be provided once the investigations are completed.

Manufacturer Narrative

Updated sections a3, b4, f6, f7, f10.The device involved in the reported event was returned to the manufacturer.After decontamination, a visual inspection on the prosthesis was performed without highlighting elements of non-conformity according to the specifications.A dimensional analysis was also performed and confirmed the correct dimensions of the returned device.In order to allow an exhaustive evaluation of the functional behavior, a migration test was performed with the valve deployed in a silicon aortic root size 21.The results confirmed that the valve migration occurred with a silicon aortic root diameter well above the maximum implant diameter as indicated for the implant of a pvf size s as per instructions for use (i.E.21 mm).Furthermore, the manufacturing and material records for the perceval plus heart valve, model pvf-s , s/n # a97659, as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model pvf-s) perceval plus heart valve at the time of manufacture and release.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device.No device malfunctions were identified during the investigations performed.Based on the information available, a definitive root cause cannot be established at this time.The manufacturer will provide an update to this reporting activity should further relevant information become available in the future.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 11143913
• MDR Text Key: 229396713
• Report Number: 1718850-2020-01226
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)220409
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2020,03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2022
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2020
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention