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

Model Number PVS25

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval implant attempt occurred.As reported, during the collapsing phase, the outflow ring of the perceval valve did not fit into the plastic sheath of the holder after several attempts.The valve was therefore not properly mounted onto the holder.After several attempts, the outflow ring was inserted into the sheath of the holder only for a couple of millimeters, and the valve stent was evidently not uniformly collapsed (in some places it protruded towards the outside).The surgeon decided to try to implant the valve anyway (even if not properly collapsed) but as soon as the holder crossed the aortotomy the valve's outflow ring snapped out of the sheath so the valve could not be properly implanted.All the members of the or staff tried to collapse the valve with two different sterile collapsing kits, but no one succeeded.After various attempts, a new perceval l valve was collapsed with the second accessory kit opened with no trouble.The new perceval l size was successfully collapsed at the first attempt.The procedure was delayed of 30min as informed (patient still in cross-clamp).The patient remained stable during the procedure, with a normal postoperative course.

Manufacturer Narrative

The valve pvs 25/l sn (b)(6) was returned to livanova for evaluation.The accessory kits used in the procedure were not returned for investigation.However, in the case history it was indicated that the collapsing difficulty of this valve also occurred with a second accessory kit.This second kit was also used to successfully collapse and implant a second valve of the same size.For this reason, even if a potential involvement of the accessories can never be completely excluded, there are reasonably indications to focus the investigation on the valve rather than on the accessories.After decontamination with formalin treatment, a visual inspection of the valve was performed to verify the compliance of the prosthesis with the specifications required at the time of manufacture and release.The results of the visual inspection did not highlight the presence of any macroscopic anomalies and/or pre-existing defects according to the specifications.Then, in order to allow an exhaustive evaluation of the functional behavior, a replication of collapsing procedure was performed.The returned valve was collapsed using a demo accessory kit in order to attempt to replicate the reported event.No problems were encountered positioning the returned valve and during the collapsing phase.Furthermore, the manufacturing and material records for the perceval heart valve, model #icv1210, s/n # (b)(6) , as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1210) perceval heart valve at the time of manufacture and release.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device because it was not possible to reproduce the claimed collapsing difficulties.The accessories used in the field were not returned, so it is not possible to totally exclude their potential involvement even if they were used to collapse a second valve without problems.Based on livanova experience with previous similar cases, it is not possible to exclude that the reported experience could be related to a wrong positioning of the perceval valve in the dual collapser.In particular this could lead to an incomplete reduction in diameter on the outflow side of the valve and a consequent partial coverage by the transparent plastic tube.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby
• MDR Report Key: 11579957
• MDR Text Key: 252327982
• Report Number: 1718850-2021-01044
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)231027
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2021
• Device Age: 16 MO
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 110