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 03/02/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer is conservatively reporting this event due to the early implantation time following the perceval implant (postoperative day 5) and due to the intraoperative procedural oversizing, which may have contributed to the reported event.However, no further investigation is warranted at this time due to the patient's pre-existing conduction abnormalities which made the patient at risk for a postoperative pacemaker implant, in agreement with the physician's feedback received.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.Device not explanted.

Event Description

On (b)(6) 2020, a patient received a perceval pvs25.It is reported that the patient received a pacemaker for an av block on postoperative day 5.A good patient outcome is reported.Per additional information received, the patient had a pre-existing bi-fascicular block, which reportedly made the patient at risk for a pacemaker implant.At the time of perceval implant, a pvs27 was initially placed, but the device was explanted before weaning the patient from bypass due to device oversizing.

• 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 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, british columbia V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 9911520
• MDR Text Key: 191914582
• Report Number: 3005687633-2020-00111
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75