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

Model Number PVS21

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Complete Heart Block (2627)

Event Date 04/07/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this event occurred in (b)(6) and the device is manufactured at our sister site - sorin group (b)(4).It therefore does not have a udi# as perceval sutureless aortic heart valves manufactured at our sister site are not sold in usa.Device not explanted.

Event Description

This event was notified to the manufacturer through the sure avr registry: a perceval size 21mm was implanted on (b)(6) 2016 via median-sternotomy.Post dilatation ballooning was done.On (b)(6) 2017, the patient exhibited syncope-complete heart block.

Event Description

This event was notified through the sure avr clinical registry: a perceval size21mm was implanted on (b)(6) 2016 via median-sternotomy.Post dilatation ballooning was done.On (b)(6) 2017, the patient exhibited syncope-complete heart block.Up-date received on january 16, 2017 based on new information received from the implanting hospital, the patient was treated with a pacemaker implant after the occurrence of the av block (10 months after perceval was implanted).Echo revealed preserved right and left ventricular function and a well seated aortic valve replacement.

• 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, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7102551
• MDR Text Key: 94344331
• Report Number: 3005687633-2017-00135
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/01/2020
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2016
• 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): Hospitalization; Other
• Patient Weight: 89