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

Model Number PVS25

Device Problem Perivalvular Leak (1457)

Patient Problems Pulmonary Edema (2020); Heart Failure (2206)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

Device not explanted.

Event Description

On (b)(6) 2013 a perceval pvs25 was implanted as part of the sure-avr trial.On (b)(6) 2018 the patient had heart failure with pulmonary edema as reported by the sure-avr clinical registry.

Manufacturer Narrative

Upon review of the of the sure-avr clinical database the site reported the event as a non-device related incident.In addition the date of the event has been updated from feb.18 to feb.23 which is reflected in section b3.Based on the information available the manufacturer is treating this event based on the site assessment as a non-device related incident and no investigations will be performed as there is no indication of a device relationship to the event.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7521016
• MDR Text Key: 108482106
• Report Number: 3005687633-2018-00156
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/03/2016
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 88 YR
• Patient Weight: 63