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

Model Number PVS27

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On (b)(6) 2017 during an avr on an obese patient who had a high creatinine level, the physician chose a perceval valve to implant as due to the higher risk nature of the case a reduction in the operative time was preferred.The physician noted that the aortic annulus was quite "wonky" and he initially thought that it was bicuspid but believe now that it was possibly quadricuspid.The valve was sized, collapsed and deployed in the usual manner.Under inspection the physician was not pleased with the seating of the valve and the way it looked in the annulus.He determined that due to the unusual nature of this patient's annulus, the best solution was to remove the perceval valve and put in a conventional sutured aortic prosthesis.As per the physician no further complications with the patient or surgery other than the added time it took to remove the perceval and suture in another valve, which was greater than 20 minutes addition to the x clamp time.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• 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 V5J5M 1; CA V5J5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 6970659
• MDR Text Key: 90029096
• Report Number: 3004478276-2017-00169
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)210730
• 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: 10/23/2017

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
• Device Operator: Physician
• Device Expiration Date: 07/30/2021
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention