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

Model Number PVS21

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 06/20/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 a patient received a perceval sutureless aortic heart valve (model unknown) as part of the (b)(6) study.The manufacturer was notified of an adverse event, migration into the lv, which occurred during the procedure.The device was removed and replaced with another valve.The site reported the outcome was recovering/resolved and the event did not meet serious sae criteria.The site also indicated the event was due to the procedure and the relationship to the device was unknown.

Event Description

On (b)(6) 2019 a patient received a perceval sutureless aortic heart valve (model unknown) as part of the japan perceval heart valve study.The manufacturer was notified of an adverse event, migration into the lv, which occurred during the procedure.The device was removed and replaced with another valve.The site reported the outcome was recovering/resolved and the event did not meet serious sae criteria.The site also indicated the event was due to the procedure and the relationship to the device was unknown.Follow-up was received on (b)(6) 2019 identifying that the device was not explanted as a result of this issue and that the device remains implanted.In addition the device sn was received.

Event Description

The manufacturer is notifying the competent authority that this case was already report in 3004478276-2019-00206, manufacturer reference etq 2019-04318.The information was incorrectly reported.The valve reported in this event was not explanted and was not involved in any adverse events.The device reported in this medwatch refers to the device used to replace the original valve which migrated as reported in etq 2019-04318.Based on this information the event has already been reported and the manufacturer is closing this event with no further investigations.Fore all future issues associated with this complaint please refer to report: 3004478276 -2019 -00206, etq 2019-04318.

Manufacturer Narrative

The manufacturer is notifying the competent authority that this case was already report in 3004478276-2019-00206, medwatch # mw-006231, manufacturer reference etq 2019-04318.The information was incorrectly reported.The valve reported in this event was not explanted and was not involved in any adverse events.The device reported in this medwatch refers to the device used to replace the original valve which migrated as reported in etq 2019-04318.Based on this information the event has already been reported and the manufacturer is closing this event with no further investigations.Fore all future issues associated with this complaint please refer to report: 3004478276 -2019 -00206, etq 2019-04318.

• 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
• MDR Report Key: 9293892
• MDR Text Key: 176133311
• Report Number: 1718850-2019-01165
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

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: Health Professional
• Device Expiration Date: 01/11/2022
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/09/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 10/09/2019; 10/09/2019
• Supplement Dates FDA Received: 01/29/2020; 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR