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

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition not presently known.
Event or Problem Description
A carbomedics standard aortic valve a5-023 was implanted on (b)(6) 2008.The valve was explanted on (b)(6) 2018 and replaced with another carbomedics standard aortic valve of the same size on (b)(6) 2018.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device 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 was notified of this event via the patient tracking registry.Livanova maintains a patient tracking registry to identify when a device has been implanted.This information is not received in the form of a conventional customer complaint, and no patient and/or device status is reported to the registry on the implant data cards.The information received therefore does not necessarily indicate the occurrence of an adverse event, and may or may not be related to the livanova device.Based on the document review performed, no manufacturing deficiencies were identified.As the device was not received for analysis, no device investigation can be performed and the root cause of the event cannot be determined.Given that the manufacturer was unable to obtain additional information about this event, it was not possible to confirm whether this was a device-related adverse event.The event was reported in a conservative manner due to limited information.Device discarded by hospital.

• Brand Name: CARBOMEDICS REDUCED PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia 13040 ; IT 13040
• MDR Report Key: 7513120
• Report Number: 3005687633-2018-00154
• Device Sequence Number: 1396238
• Product Code: LWQ
• UDI-Device Identifier: 08022057012623
• UDI-Public: (01)08022057012623(240)A5-023(17)120223
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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: 02/23/2012
• Device Model Number: CPHV
• Device Catalogue Number: A5-023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 09/17/2018
• 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: 53 YR