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

Model Number PVS25

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complete Heart Block (2627)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

The manufacturer was informed on this event through the (b)(6) registry.On (b)(6) 2020, a patient received a perceval pvs25 in aortic position.At the time of the perceval implant, the following concomitant procedures were performed: cabg, mitral valve/annulus replacement and a tricuspid repair.On (b)(6) 2020, the patient experienced a complete heart block requiring the implant of a permanent pacemaker on (b)(6) 2020.The patient was discharged home on (b)(6) 2020 with a good device functionality (13mmhg, no central/perivalvular leak).

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2020, a patient received a perceval pvs25 in aortic position.At the time of the perceval implant, the following concomitant procedures were performed: cabg, mitral valve/annulus replacement and a tricuspid repair.At the time of the perceval implant, the device reportedly appeared well seated, but the position of the balloon was too close to the newly replaced mitral valve and pushed the mitral valve out of the annulus.Therefore, it was determined that ballooning the aortic valve was not a safe choice for the patient, and no post-dilatation ballooning was performed.On (b)(6) 2020, the patient experienced a complete heart block requiring the implant of a permanent pacemaker on (b)(6) 2020.The event was reported as valve-related.The patient was discharged home on (b)(6) 2020 with a good device functionality (13mmhg, no central/perivalvular leak).

Manufacturer Narrative

Fields updated: b4, b5, g4, g7, h1, h2, h6.The manufacturing and material records for the perceval heart valve, model #icv1210, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1210) perceval heart valve at the time of manufacture and release.As the device remains implanted, 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: 10454924
• MDR Text Key: 204410534
• Report Number: 3004478276-2020-00178
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)230205
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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: 02/05/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 119