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

Model Number PVS21

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/14/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device not explanted.

Event Description

The manufacturer was informed on this event through the (b)(6) registry.On (b)(6) 2012, an (b)(6) female patient received a perceval pvs21 to replace the native aortic valve.The procedure was performed in mini-thoracotomy and no concomitant procedures occurred.At discharge from the hospital, the echo showed a good device functionality (8mmhg mean gradient, no leaks).During the follow-up visit on (b)(6) 2013, the device was observed through the echo, which showed a mean gradient of 6mmhg and a central leak of 1+ (adverse event, non-structural dysfunction).The echo performed on (b)(6) 2015 showed an increase in the central leak (2+).

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 remains implanted in the patient, further investigation is not possible at this time.Based on the document review performed, no manufacturing deficiencies were identified.Furthermore, according to the information provided by the site, there are no plans for re-intervention.As such, it can be reasonably concluded that no serious injury for the patient is identified.However, since no further investigation on the device could be performed, the root cause of the event remains unknown.

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2012, an 81 years old female patient received a perceval pvs21 to replace the native aortic valve.The procedure was performed in mini-thoracotomy and no concomitant procedures occurred.At discharge from the hospital, the echo showed a good device functionality (8mmhg mean gradient, no leaks).During the follow-up visit on 14 nov 2013, the device was observed through the echo, which showed a mean gradient of 6mmhg and a central leak of 1+ (adverse event, non-structural dysfunction).The echo performed on 17 mar 2015 showed an increase in the central leak (2+).The nyha class reported in the last follow up phone call was class iii.The site informed that there is no plan for a re-intervention.

• 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: 8217932
• MDR Text Key: 132098492
• Report Number: 3005687633-2019-00097
• 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: 02/07/2019

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: 02/06/2014
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 56