MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per information received, the event was probably caused by mis-sizing at the implant.The review of the device history record is ongoing.Valve not available.
Event or Problem Description
Received e-mail dated 31 aug 2016 from a patient: hello, my name is (b)(6) and i had an aortic heart valve replaced with one of yours on (b)(6) 2011 at (b)(6).It only lasted 4 years, i was in terrible shape last year.You see my doctor used on that was under sized, my bsa is 2.2 and he used a size 23.It leaked from the very first day, but they mislead and assured me that it was fine.So like i said last year the pressure got to it and i damn near died.They were hacks and tried to plug it cover up their mistake.Those blew out too.And i opted to go to (b)(6), they too noted the valve size was too small.They used an on-x 27-29, 4-6 sizes bigger i believe than yours.I hope it was not your chart that confused them, i am very unhappy with what happened.And paying for 3 surgeries when 1 should have been all i needed.Info from patient tracking as of 07 sep 2016: our record shows that the patient has a s5-023 sn # (b)(4) implanted on (b)(6) 2011 at (b)(6).Patient male dob (b)(6).
Additional Manufacturer Narrative
The complete manufacturing and material records for the carbomedics top hat mechanical heart valve, model: cphv s/n (b)(4), were retrieved and reviewed by quality control at livanova.The results confirmed that this valve satisfied all material, visual, and performance standards required for a carbomedics top hat mechanical heart valve model: cphv at the time of manufacture and release.No further details have been provided to date.The manufacturer has requested details of the patient's current physician so that we may contact him/her for more information regarding the device.No further investigation is possible at this time.
Event or Problem Description
On (b)(6) 2016 the manufacturer was contacted directly by a patient relating to a carbomedics top hat mechanical heart valve (s5-023, sn # (b)(4) that was implanted on (b)(6) 2011.The patient raised concerns of the device that was implanted that 'lasted 4 years' and was concerned the device was undersized.The patient had a bsa 2.2.He commented that a leak was observed after implant, re-operation was performed in 2015 with no device explant.A second re-operation was performed at a different facility with removal of the top hat device and an on-x size 27-29 was then implanted.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 5984124
• Report Number: 3005687633-2016-00017
• Device Sequence Number: 1397570
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)120426
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 04/26/2012
• Device Model Number: CPHV
• Device Catalogue Number: S5-023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2016
• Supplement Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR