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

Model Number CPHV

Device Problem Incomplete Coaptation (2507)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

Still not returned to the mfr.

Event Description

The manufacturer was notified on 7 january 2016 about an explanted carbomedics prosthesis heart valve (cphv) top hat s5-021 sn (b)(4).The valve was explanted at the (b)(5) hospital - (b)(6).The patient progressively showed short of breath over the previous 3 months, with increased velocities over mechanical aortic valve, consistent with recurrent stenosis via the thrombus, maybe incomplete leaflet opening.With the patient and family was decided to go ahead with the aortic valve replacement (avr).Once opened the aorta, the valve appeared too big for the size and in short it causing tilting of the valve and incomplete opening and significant obstruction from subaortic membrane, most likely from pledgets.Pannus or some kind of membrane underneath the valve was noticed.The valve was removed, upon grabbing it, the carbon had shattered requiring extensive removal of all pieces.Tissue valve #21mm of different brand was implanted instead.Good lv function with poor rv function after operation.The patient was then taken to cvicu in stable but very very critical condition.

Manufacturer Narrative

The valve was implanted on (b)(6) 2007, removed on (b)(6) 2015 and finally sent to the pathologist laboratory (associated pathologist chartered at (b)(6)), reporting the following: "received in formalin subaortic membrane 1.8x0.4x0.3 cm crescent-shaped piece of red-tan fibromembranous tissue.Fibrous and myxoid tissue with mild chronic inflammation.Small amount of suture-type material." as per information received from the field, after the analysis, the laboratory discarded the valve.As the device was not available for evaluation, our investigation was limited to a review of the device history record for this device.The device history record review showed that the above mentioned device satisfied all material, dimensional, and performance standards required for a carbomedics top hat aortic heart valve prosthesis at the time of manufacture and release, including a functional test performed with a hydrodynamic tester performed on (b)(6) 2007.Device scraped by the pathologist lab.

• 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: 5413682
• MDR Text Key: 37569763
• Report Number: 3005687633-2016-00002
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: 08022057012906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/19/2012
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2007
• 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): Required Intervention
• Patient Age: 65 YR