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

Model Number PVS21

Device Problem Leak/Splash (1354)

Patient Problem Aortic Insufficiency (1715)

Event Date 09/26/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 a patient received a perceval pvs21 sutureless aortic heart valve implant as part of an avr.It was reported that on the echo they saw huge pvl and central leakage.Then they explanted the valve.They saw one leaflet which looked tighter and lower than the other 2 leaflets.Sizing was no problem (snug-fit).They took a new valve, size small, which was implanted very well.The site hypothesized the first valve could be damaged during collapsing or damaged out of factory, or just implanted in a wrong way.

Manufacturer Narrative

The manufacturer received follow-up from the site identifying no further information is available regarding this event.A review of the device history records was performed.The review of the manufacturing and quality control data filed in the dhr of the perceval heart valve prosthesis pvs 21/s sn (b)(6), confirmed that each manufacturing and inspection operation was followed by the appropriate signature and date, indicating that the process was performed in accordance with livanova specifications at the time of manufacture and release.The valve pvs 21/s sn (b)(6) was returned to livanova for evaluation and it was received on october 24, 2019.A preliminary visual inspection was performed in order to record the gross appearance of the returned valve in its as received conditions.Photographs of the device were taken during this step.The visual inspection performed on the returned prosthesis valve did not highlight pre-existing defects.A dimensional verification confirmed that the returned pvs 21/s valve meets the specifications.In order to allow an exhaustive evaluation of the functional behavior, a simulation of collapsing, deployment and ballooning phases was performed using the returned valve and a demo accessory kit in order to attempt to replicate the reported event, according to the indication included in the ifu, perceval s ¿ sutureless aortic heart valve ¿ instructions for use ¿ ic0215001345 rev.J.In particular, the deployment and ballooning phases were performed in a silicon aortic root, size 21, reinforced at the annulus level by means of an o-ring.The collapsing replication highlighted an incorrect configuration of the metallic elements resulting in overlapping.It is not possible to determine if this feature was the one claimed in the case history or if it is related to the manipulation during the implant/ explant procedure as confirmation of the site hypotheses.Nevertheless, there is a specific warning in the pvs ifu to check the valve struts before the implant.Thus, if this procedure has been correctly followed it is possible to state that the deformation occurred and was undetected or that it did not happen before the implantation.The deployment simulation performed on the returned valve did not highlight anomalies and/or deformations at the annulus level.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device.The accessories used in the field were not returned, so it is not possible to state their potential involvement.Nevertheless, as reasonable root cause, it is not possible to totally exclude a mishandling, which occurred during the collapsing / implant procedure and which compromised the entire implant procedure.At this time the root cause cannot be established.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9300226
• MDR Text Key: 176133583
• Report Number: 1718850-2019-01166
• Device Sequence Number: 1
• Product Code: LWR
• 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: 10/10/2019,12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/10/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2019
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention