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  

Manufacturer Narrative

Device not available.

Event Description

On (b)(6) 2019 a patient received a perceval sutureless aortic heart valve (model unknown) as part of the (b)(4) 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.

Manufacturer Narrative

Follow-up was received on dec.31, 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

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 dec.31, 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: (b)(4).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 (b)(4).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, (b)(4).

Manufacturer Narrative

The manufacturer is notifying the competent authority that this case was already report in 3004478276-2019-00206, medwatch#: mw-006231, manufacturer reference:(b)(4).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 (b)(4).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, (b)(4).

• 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: 9293917
• MDR Text Key: 177819071
• Report Number: 3004478276-2019-00307
• 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,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• 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
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR