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

Model Number PVS25

Device Problems Perivalvular Leak (1457); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Insufficiency (1715); Pseudoaneurysm (2605)

Event Date 07/01/2013

Event Type  Injury  

Manufacturer Narrative

Device location not presently known.

Event Description

On (b)(6) 2013, a (b)(6) male patient received a pvs25 to replace the native aortic valve.The procedure was performed in mini-thoracotomy and no concomitant procedures occurred.At discharge, the echo showed a mean transvalvular gradient of 19mmhg and no central/perivalvular leaks.On (b)(6) 2013, the patient was re-operated due to a pseudoaneurysm of the aortic root with periprosthetic and intraprostatic insufficiency (insufficiency grade not reported).The site reported the event as device-related (non-structural valve dysfunction).The device was explanted and replaced with a perceval pvs25 sn: (b)(4).The aortic annulus was reconstructed and the aneurysm sutured.

Manufacturer Narrative

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.Since the device was disposed of by the hospital, further investigation is not possible.Based on the review of the manufacturing and quality records, no device problems were identified.The pseudoaneurysm is a procedure-related complication and the device can be reasonably excluded as a root cause of its formation.It is possible that the reported insufficiency originated as a consequence of the pseudoaneurysm formation.However, since the device was not received for analysis, the root cause of the reported insufficiency cannot be confirmed at this time.

• 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
• MDR Report Key: 8249737
• MDR Text Key: 133135240
• Report Number: 3005687633-2019-00102
• 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: health professional,study
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2016
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 84