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

Model Number ICV1211

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer is in the process of attempting to obtain additional information about this event.

Event Description

It was reported that a perceval pvs27 was implanted and explanted, and replaced by perceval pvs25 on the same day.No other information was provided.

Manufacturer Narrative

Based on the information provided, the event is attributable to mis-sizing.There is no apparent device issue.No further investigation is warranted.

Event Description

A perceval pvs27 was explanted and replaced with a smaller perceval pvs25.The valve was reportedly replaced due to mis-sizing.The patient outcome was good.No other information was provided.

• 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
• MDR Report Key: 7698921
• MDR Text Key: 114329488
• Report Number: 3004478276-2018-00242
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)190427
• 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
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2019
• Device Model Number: ICV1211
• Device Catalogue Number: PVS27
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR