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

Model Number	PVS23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the event narrative provided by the physician, the patient had a bicuspid valve and the physician wanted to make the perceval work.Ultimately, the physician decided the perceval was not suitable, and implanted a ew magna valve in its place.In it possible that the patient annulus anatomy was not suitable for perceval valve.
Event or Problem Description
This was a bicuspid valve and the surgeon wanted to try and make a perceval valve work.The device was implanted, however the patient was better suited for a stented valve so the device was explanted and replaced with an ew magna valve.There was about 25 min added to the case.The patient is doing fine.The event occurred on (b)(6) 2017, and the manufacturer was notified on 31-aug-2017.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 6902887
• Report Number: 3004478276-2017-00163
• Device Sequence Number: 10964530
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)191204
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 12/04/2019
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR