MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS25

Device Problem Insufficient Information (3190)

Patient Problem Endocarditis (1834)

Event Date 06/01/2016

Event Type  malfunction  

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, no further investigation is possible at this time.Based on the available information, the root cause of the reported event cannot be definitively stated.However, based on the document review performed, no manufacturing nor quality deficits were identified.Endocarditis is listed as a possible adverse event in the perceval instructions for use (ifu).The event is, therefore, a known inherent risk of the device.The manufacturer has requested additional information on this event.Should further information be received, an update to this reporting activity will be provided.Device still implanted.

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(4) 2013, a patient received a pvs25 in aortic position.The procedure occurred in mini sternotomy and no concomitant procedures were performed.A good valve functionality was detected at discharge and at 1 year follow up ((b)(6)2014).The manufacturer was informed that on (b)(6) 2016 the patient had valve endocarditis, primary onset and microorganism unknown.There is no indication of treatment or re-intervention on the database.

Manufacturer Narrative

Based on the additional information received, the device remains implanted with a good outcome after the targeted antibiotic therapy.Given the late occurrence of endocarditis after implant, and confirmation from the site that the origin seems to be linked to cholecystitis (for which the patient was operated again in (b)(6) 2018), it is reasonable to conclude that the root cause of the reported event was related to patient factors, and not related to the device.

Event Description

Per additional information received, the manufacturer was informed that no new surgery was performed but the endocarditis was treated conservatively with targeted antibiotic therapy with subsequent healing.As reported, the pathogen is unknown because the hospitalization took place in another hospital, but the origin seems to be linked to cholecystitis.No echocardiographic findings relating to the prosthesis is available but a subsequent well-being was reported after the episode.The patient had a favorable outcome after the event and was in full well-being until (b)(6) 2018 when he underwent a gallbladder removal surgery for gangrenous cholecystitis with peritonitis.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 11025050
• MDR Text Key: 244002451
• Report Number: 3005687633-2020-00154
• 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: 01/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2016
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 69