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

Model Number	A5-019
Medical Device Problem Codes	Incomplete Coaptation (2507); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/12/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Limited information has been provided on this event to the manufacturer.The information received to date is of patient death the day after implant of carbomedics 19 aortic and the cause surgeon observed was stuck valve.The manufacturer has requested further information from the physician however the hospital is unwilling to disclose any further information or clinical data for this event.Device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2017, the physician implanted mechanical carbomedics 19 aortic.On (b)(6) 2017 the patient died.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device (sn# (b)(4)) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.The manufacturer has requested further information from the physician however the hospital is unwilling to disclose any further information or clinical data for this event.

• 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 snc; saluggia,, vc 13040 ; IT 13040
• MDR Report Key: 6577227
• Report Number: 3005687633-2017-00042
• Device Sequence Number: 18989692
• Product Code: LWQ
• UDI-Device Identifier: 08022057012609
• UDI-Public: (01)08022057012609(240)A5-019(17)200119
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: Physician
• Device Expiration Date: 01/19/2020
• Device Model Number: A5-019
• Device Catalogue Number: A5-019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: Death