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

Model Number PVS21

Device Problem Incomplete Coaptation (2507)

Patient Problem No Code Available (3191)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

This mdr was already submitted (b)(6) 2018 and resubmitted due to missing 3rd acknowledgment.Device not available.

Event Description

On (b)(6)2018 a perceval pvs21 was implanted.After the implant the valve was explanted due to a central leak.The patient then had a full root replacement.

Manufacturer Narrative

New event description based on information received sep 19, 2018: on (b)(6) 2018 a perceval pvs21 was implanted.After the implant the valve was explanted due to a central leak.The reported cause of the event was patient anatomy and the event was reported to be not valve related.The issue added less than 5 minutes of added x-clamp time.The patient then had a full root replacement.The manufacturing and material records for the perceval heart valve, model #icv1208 , s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Based on the additional information provided the root cause is attributable to the patient condition and is not device related.Based on this no further investigations are required.Fields changed.

Event Description

On (b)(6) 2018 a perceval pvs21 was implanted.After the implant the valve was explanted due to a central leak.The reported cause of the event was patient anatomy and the event was reported to be not valve related.The issue added less than 5 minutes of added x-clamp time.The patient then had a full root replacement.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 7689101
• MDR Text Key: 114007709
• Report Number: 3004478276-2018-00235
• Device Sequence Number: 1
• Product Code: LWR
• 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: 10/04/2018

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: No Information
• Device Expiration Date: 07/09/2020
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 09/19/2018
• Supplement Dates FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention