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

Model Number PVS21

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

The manufacturer was informed of a dysfunction with the perceval valve pvs21.The implant date is presently unknown and a re-intervention is scheduled to replace the prosthesis with another biological valve, although details on the re-do surgery have not been provided yet.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208 , 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 #icv1208) perceval heart valve at the time of manufacture and release.Since the manufacturer has not yet received confirmation on the re-intervention (i.E.Device remains implanted), no further device investigation was possible at this time.The manufacturer attempted to retrieve additional information on the event and on the type of dysfunction noted, but no further details has been received to date.Based on the available information, it is not possible to draw a definitive conclusion on the reported event.However, from the document review performed, no manufacturing deficits were identified.Should further information be provided in the future, the manufacturer will provide an update to this reporting activity.

• Brand Name: PERCEVAL 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: 10764331
• MDR Text Key: 213941986
• Report Number: 1718850-2020-01183
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)200205
• 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: 10/01/2020,12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2020
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/13/2020
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR