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

Model Number PVS21

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complete Heart Block (2627)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

Device not explanted.

Event Description

On (b)(6) 2019 a patient received a perceval pvs21 sutureless aortic heart valve implant.The manufacturer was notified of the following adverse event.Perceval was implanted by mics avr with intercostal thoracotomy.Pre-operative finding were as follows.Electrocardiogram: regular sinus rhythm.Echo: type 1 bicuspid aortic valve, aortic regurgitation was not observed.After surgery, transient rbbb(right bundle branch block) was occurred, but it was improved.In the middle of the night of the day of operation, av block (morbitz) was observed repeatedly, and rbbb was occurred again.On (b)(6) 2019, the appearance frequency of av block(morbitz) increased, and heart rate beat was 40bpm level.On (b)(6) 2019, permanent pace maker (ddd mode) was implanted due to complete av block.The patient became asystole while implanting second lead, but when she returned to her-self pulse, av block was disappeared and she was improved to the regular sinus rhythm.On (b)(6) 2019, she was regular sinus rhythm, but she was discharged with pacemaker in place.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208 , 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 #icv1208) perceval heart valve at the time of manufacture and release.As the device was not received for analysis, no device investigation can be performed and the root cause of the event cannot be determined.However, based on the document review performed, no manufacturing deficiencies were identified.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is, therefore, a known, inherent risk of the procedure, and it is listed among the potential adverse events in the perceval ifu.

• 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: 9288410
• MDR Text Key: 165372260
• Report Number: 3004478276-2019-00305
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)211121
• Combination Product (y/n): N
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2019
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 71 YR
• Patient Weight: 60