MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVES

Model Number PVS25

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complete Heart Block (2627)

Event Date 10/15/2019

Event Type  Injury  

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2019, a patient received a perceval pvs25 in aortic position.No concomitant procedures were performed.The patient received a permanent pacemaker on 15 oct 2019 due to an atrio-ventricular block grade iii, indicated as a new conduction abnormality.The patient was discharged on (b)(6) 2019 with a good device functionality (no central/perivalvular leaks, mean gradient 14mmhg).No adverse events are reported in the database for this patient.

Manufacturer Narrative

A complete manufacturing and material records review for the device (model: pvs25, sn: (b)(6)) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Since the device was not explanted, no further investigation can be performed at this time.Based on the available information, the root cause of the event reported cannot be definitively stated.However, based on the documents review performed, no manufacturing deficits 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.

Manufacturer Narrative

Livanova is providing a corrected section e.Upon notification, this event was mistakenly associated with the wrong healthcare facility information due to a clerical error.This information has now been corrected in this report.Livanova would like to clarify that the reporting activity is not otherwise impacted by this corrected information, as the description of the event, investigation performed, and root cause analysis remain unchanged as a result of the discrepancy noted.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9386349
• MDR Text Key: 168621558
• Report Number: 1718850-2019-01182
• 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: 10/30/2019,05/25/2020

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: 06/27/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2019
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 10/30/2019; 10/30/2019
• Supplement Dates FDA Received: 12/12/2019; 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 69