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

Model Number PVS23

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Obstruction/Occlusion (2422); Vascular System (Circulation), Impaired (2572)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

On (b)(6) 2020, a patient received a perceval pvs23 in aortic position.Although no problem was found immediately after perceval indwell via the right small thoracotomy approach, postoperatively, the blood flow was found partially blocked by compression with the strut jail at the left coronary artery (lca) entrance.Bypass surgery was additionally performed on (b)(6) 2020.

Manufacturer Narrative

The manufacturer has provided an updated summary based on the new information received.A review of the device history records review in undergoing and an updated report will be provided upon completion of the investigation.

Event Description

On (b)(6) 2020, a patient received a perceval pvs23 in aortic position.Although no problem was found immediately after perceval indwell via the right small thoracotomy approach, postoperatively (i.E.After moving the patient to the icu), the blood flow was found partially blocked by compression with the strut jail at the left coronary artery (lca) entrance.Bypass surgery was additionally performed on (b)(6) 2020.The patient recovered well after the additional procedure performed.Based on the medical judgment received at the time of the follow up, the suspected root cause were attributed to the patient anatomy (position of the coronary ostium) and the procedure (insufficient visual confirmation due to mics approach).

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.Since the device remains implanted, no further investigation is possible at this time.Based on the information available, the root cause of the reported event was attributed to the patient anatomy (position of the coronary ostium) and the procedure (insufficient visual confirmation due to mics approach).No manufacturing deficits were identified during the document review performed.No further investigation is warranted at this time.

• 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: 10653416
• MDR Text Key: 210576377
• Report Number: 3004478276-2020-00211
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230403
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR