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

Model Number PVS21

Device Problem Material Deformation (2976)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 10/14/2014

Event Type  Injury  

Manufacturer Narrative

The patient's clinical condition and risk factors may have contributed to this event, as dyslipidemia and hypertension are known risk factors for structural valve deterioration.Device available but not yet received.

Event Description

A (b)(6) female patient, suffering from renal failure, dyslipidemia and systemic hypertension underwent an aortic valve replacement.The preoperative cardiac status revealed stable angina.She was in the preoperative functional nyha class ii (logistic euroscore 5.13% and sts score 17.0%).The patient received a 21 mm percival s valve implant on (b)(6) 2011.On the day of the surgery, bradycardia was diagnosed, which required external pacing during the following 24 hours.The event was judged to be surgery-related and was resolved on (b)(6) 2011.On (b)(6) intracardiac bleeding also occurred, and was judged to be surgery-related.The event was resolved by transfusion on the same day.At 3-year follow-up in (b)(6) 2014 by the referring physician, no particular events were reported.On (b)(6) 2014 the patient underwent a valve-in-valve because of a stenotic percival (mean gradient 60 mmhg, insufficiency grade iii).

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.No further analysis on the device is possible as the device is not available.

Event Description

On january 16, the patient outcome was reported as 'alive'.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7176889
• MDR Text Key: 96809384
• Report Number: 3005687633-2018-00102
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR