MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICSTOP HAT AORTIC MECHANICAL HEART VALVE; CPHV TOP HAT

Catalog Number S5-021

Device Problem Increase in Pressure (1491)

Patient Problem Aortic Valve Stenosis (1717)

Event Type  Injury  

Manufacturer Narrative

Valve still implanted.

Event Description

The manufacturer was notified on (b)(6) 2016 about a pressure gradient unusually high: peak gradient=52.6.Mpg=31.1.With a carbomedics top hat (sn unknown) size 21 implanted in the early 2015 at the "(b)(6) hospital." the device is still implanted.Patient's past history: mvr (mitral valve replacement) in 2005 with prosthesis valve size 29 of different brand.

Manufacturer Narrative

No additional data about the implanted devices were communicated, except that the valve is still implanted and the patient health status was fine.Valve still implanted.

• Brand Name: CARBOMEDICSTOP HAT AORTIC MECHANICAL HEART VALVE
• Type of Device: CPHV TOP HAT
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: giovanni bergamasco ; via crescentino sn; saluggia, vc 13040 ; IT 13040 ; 9161487034
• MDR Report Key: 5463443
• MDR Text Key: 39130458
• Report Number: 3005687633-2016-00005
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: 08022057012906
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 69