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

Model Number	R5-029
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported in a conservative manner due to limited information known to date.The manufacturer is in the process of following up with the physician to determine further details on the event.Not yet determined if device available.
Event or Problem Description
On september 14, 2017 the manufacturer was notified through patient tracking of a carbomedics reduced aortic valve that was 'wasted' on (b)(6) 2017 and a replacement aortic root was performed.
Additional Manufacturer Narrative
Despite multiple attempts, the manufacturer was unable to follow up to determine the details of this event.As the device was not received for analysis, and limited information was available, the device could not be investigated and the root cause of the event cannot be determined.According to the event information available, the device in question was said to be "wasted".As such, there is no indication of patient involvement, and further investigation is not warranted based on the available information.Should further information become available at a later date, appropriate investigative actions will be taken.

• Brand Name: CARBOMEDICS REDUCED AORTIC VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada crescentino snc; saluggia,, vc 13040 ; IT 13040
• MDR Report Key: 6948034
• Report Number: 3005687633-2017-00101
• Device Sequence Number: 10889044
• Product Code: LWQ
• UDI-Device Identifier: 08022057012814
• UDI-Public: (01)08022057012814(240)R5-029(17)180128
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2017

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: 01/28/2018
• Device Model Number: R5-029
• Device Catalogue Number: R5-029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 12/15/2017
• 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: Required Intervention
• Patient Age: 42 YR