MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICSSTANDARD AORTIC MECHANICAL HEART VALVE; CPHV STANDARD AORTIC

Model Number A5

Device Problem Malposition of Device (2616)

Patient Problem Death (1802)

Event Date 03/30/2015

Event Type  Death  

Event Description

The manufacturer was notified on (b)(4) 2015 of an incident regarding a carbomedics mechanical heart valve (a5-023) that occurred on (b)(6) 2015.Apparently they had to take it out and re-mount it for some reason during the procedure.They then had all sorts of problems.The heart just kept filling up.Eventually they realized the valve had been re-mounted upside down, so when it was passed to them they implanted it upside down.The patient was on ecmo on itu.They have raised an "mhl", an internal serious incident alert process.They are not treating this as a complaint and are taking full responsibility for their mistake but they do need something in writing from sorin stating that valve should not be re-used.Having said this, they have notified the (b)(6).On (b)(6) 2015, the manufacturer received a confirmation update from the hospital that the patient eventually died on (b)(6) 2015.

Manufacturer Narrative

Result = the complete manufacturing and material records for the subject valve will be retrieved and reviewed by quality control at sorin (b)(4).The device will be evaluated, once it is returned to the manufacturer.Device is not yet returned.

Manufacturer Narrative

The event was caused by implanting the valve upside down.This happened because during surgery the prosthesis was removed from the holder and then incorrectly remounted on it by the nurse assisting the surgeon.Reinserting the valve on the holder is contrary to the instructions for use.The review of the instructions for use showed that the direction of flow is well described, instructions on handling the prosthesis are adequate and indication not to reinsert the valve on the holder is clearly stated.No additional elements resulted from the examination of the returned device as it appeared normal and free from manufacturing defects.

Event Description

Sorin representative received a phone call ((b)(6) 2015) from the theatre manager who informed that they had an incident the previous week regarding a carbomedics a5 mhv.Apparently they'd had to take the valve out and re-mount it for some reason during the procedure.They then had all sorts of problems.The heart just kept filling up.Eventually they realised the valve had been re mounted upside down so when it was passed to them they mounted the valve upside down.The patient was on ecmo on itu.They are not treating this as a complaint and are taking full responsibility for their mistake but they do need something in writing from us stating valves should not be re used.Having said this, they have notified the mhra.Patient eventually died on (b)(6) 2015.

• Brand Name: CARBOMEDICSSTANDARD AORTIC MECHANICAL HEART VALVE
• Type of Device: CPHV STANDARD AORTIC
• 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: 4745548
• MDR Text Key: 5769856
• Report Number: 3005687633-2015-00004
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,hea
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2019
• Device Model Number: A5
• Device Catalogue Number: A5-023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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): Death; Other
• Patient Age: 72 YR
• Patient Weight: 80