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

Model Number PVS25

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 10/24/2014

Event Type  Death  

Manufacturer Narrative

The event is reported in a conservative manner since there is no available information on the device functionality in the two years prior to the patient's death.Since the device was not explanted, a full investigation on the prosthesis cannot be performed.A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.

Event Description

The manufacturer was notified on this event through the sure avr database.On (b)(6) 2012, a (b)(6) female patient received a percival pvs25 to replace the native stenotic aortic valve.The procedure was performed in partial sternotomy and no concomitant procedures occurred.At discharge, the patient was in atrial fibrillation and the echo showed a good functionality of the prosthesis (12mmhg and no central/perivalvular leaks).The patient died on (b)(6) 2014 due to worsening of heart failure.Several adverse events are reported for this patient (all deemed not device-related by the site): cardiac arrhythmia on (b)(6) 2012; an avb grade iii on the second post-operative day, requiring a temporary pacemaker; mild lung failure and renal failure were reported on (b)(6) 2012; blood-serum pleural effusion treated by evacuative thoracentesis on (b)(6) 2012; 5 hospitalization were reported in the period between the discharge and the second follow-up visit because of respiratory lung failure.No valve-related adverse events are reported.

Manufacturer Narrative

Submitted follow-up report to update.Based on the quality and manufacturing records review, no manufacturing deficiencies were identified.Since limited information is currently available on the valve functionality prior to the patient's death, the event has been reported in a conservative manner.However, since no autopsy was performed and the device was not explanted, the root cause remains unknown at this time.

Manufacturer Narrative

Based on the information received from the site, no device dysfunctions were observed prior to the patient's death.As such, there is no sufficient evidence to link the reported event with the device.Therefore, based on the information available, the event is deemed not device related and no further investigation is warranted at this time.

Event Description

The manufacturer was notified on this event through the sure avr database.On (b)(6) 2012, a (b)(6) female patient received a perceval pvs25 to replace the native stenotic aortic valve.The procedure was performed in partial sternotomy and no concomitant procedures occurred.It is reported that the patient died on (b)(6) 2014, due to worsening of heart failure.The device functionality was observed at discharge and in march 2013 with the following findings: on 23 oct 2012 the mean gradient was12mmhg, the ejection fraction 50%, and no central/perivalvular leaks were observed; in march 2013 the mean gradient was 11mmhg, the ejection fraction 15% and no perivalvular/central leaks were reported.Additional information received from the site confirmed that no further follow-up visits were performed since the patient passed away before the visits could have been planned.The device was considered normal, and the patient's death may not be related to the device.Several adverse events are reported for this patient (all deemed not device-related by the site): cardiac arrhythmia on (b)(6) 2012; an avb grade iii on the second postoperative day, requiring a temporary pacemaker; mild lung failure and renal failure were reported on (b)(6) 2012; blood-serum pleural effusion treated by evacuative thoracentesis on (b)(6) 2012; 5 hospitalization were reported in the period between the discharge and the second follow-up visit because of respiratory lung failure.No valve-related adverse events are reported.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 8194539
• MDR Text Key: 131367588
• Report Number: 3005687633-2018-00246
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2019

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: 06/15/2015
• 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
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/24/2018
• Supplement Dates Manufacturer Received: 01/08/2019; 01/16/2019
• Supplement Dates FDA Received: 01/08/2019; 01/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 57