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

Model Number PVS23

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 02/06/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs23 was implanted through rat procedure.On the following day, feb 6th, hematoma developed and the perceval valve was explanted.The patient ultimately received an inspiris valve by midline incision.No further information about the event and the patient was received at this time.

Manufacturer Narrative

The device involved in the reported event was returned to the manufacturer and it was received on (b)(6) 2021.The valve was visually inspected according to the specifications required at the time of manufacture and release.No pre-existing defects were identified; the height of each leaflet was verified and resulted in compliance.The pericardium appeared slightly darker than normal and with presence of some organic residues, compatible with the implant of the device.The dimensional analysis confirmed the compliance of the device with the dimensional specifications required for a perceval valve model pvs23.Based on the performed analyses (visual and dimensional), the reported event cannot be explained by any factor intrinsic in the involved device.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(6), 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 #icv1209) perceval heart valve at the time of manufacture and release.The results and conclusions previously submitted remains unchanged.Based on the manufacturer's investigation, no problem was detected in the device involved to this event.As such, based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device.The hematoma formation detected postoperatively could have resulted from the procedure, and patient's specific factors may have also contributed to it.Ultimately, since no further information was received , a definitive root cause cannot be established at this time.The manufacturer will revisit the case should further information be provided in the future.

• 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: 11467504
• MDR Text Key: 239499655
• Report Number: 3004478276-2021-00134
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230610
• 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,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 53