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

Model Number PVS27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Death (1802); Unspecified Infection (1930)

Event Date 03/28/2018

Event Type  Death  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1211 , s/n # (b)(4), 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 #icv1211) perceval heart valve at the time of manufacture and release.Based on the results of the document review performed, no manufacturing deficits are suspected.Furthermore, based on the event information provided, no device failure was suspected.The event was reported in a conservative manner; however, the event is ultimately deemed to be not device-related.The perceval instructions for use state that "the risks or potential adverse events.Associated with cardiac valve replacement with a bioprosthesis include, but may not be limited to.Endocarditis, heart failure,.".As such, this event is a known, inherent risk of the procedure.Device not returned.

Event Description

A perceval pvs27 was implanted on (b)(6) 2018.The valve was explanted and replaced with a pvs25 on (b)(6) 2018.On (b)(6) 2018, the manufacturer received additional information: following implant of the size 27 perceval valve, the patient developed an aortic root abcess and infection, requiring explant of the perceval valve.The prosthesis was in tact and working well at the time of explant.The valve was replaced with a size 25 perceval valve, as reconstruction due to infection and debridement was required, which reduced the size of the outflow tract.Following the reoperation, the patient developed ischemic gut and died about a week later.It was reported that there were no concerns with the prosthesis.

• 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 V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc 13040 ; CA 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 7489073
• MDR Text Key: 107435686
• Report Number: 3004478276-2018-00182
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)211103
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/03/2021
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 72 YR