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

Model Number	CPHV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); No Information (3190)
Date of Event	12/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2015 a patient received a carbomedics standard mechanical mitral valve, m7-025.The manufacturer was notified on (b)(6) 2018 that the device had been explanted.No additional information was received.
Additional Manufacturer Narrative
The manufacturer received additional information from the site on apr.02, 2019.The following updated event summary has been included in section b5: on (b)(6) 2015 a patient received a carbomedics standard mechanical mitral valve, m7-025.The manufacturer was notified on that the device had been explanted on (b)(6) 2018.The device was explanted due to valve thrombosis.No device malfunctions were identified.The device is not available for return and analysis as it was sent to pathology per site explant protocol.The patient was discharged and sent home.Information regarding the device used as a replacement was not provided.No information regarding the device functionality prior to the event is available.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.Based on the above information the event is attributable to valve thrombosis requiring reoperation and explant.Because the device is not available for return and analysis no further investigations are possible at this time.The root cause of the thrombosis is thus unknown at this time.Fields changed: b4, b5, d7, g4, g7, h2, h6.
Event or Problem Description
On (b)(6)2015 a patient received a carbomedics standard mechanical mitral valve, m7-025.The manufacturer was notified on that the device had been explanted on (b)(6) 2018.The device was explanted due to valve thrombosis.No device malfunctions were identified.The device is not available for return and analysis as it was sent to pathology per site explant protocol.The patient was discharged and sent home.Information regarding the device used as a replacement was not provided.No information regarding the device functionality prior to the event is available.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8262580
• Report Number: 3005687633-2019-00104
• Device Sequence Number: 16658324
• Product Code: LWQ
• UDI-Device Identifier: 08022057012715
• UDI-Public: (01)08022057012715(240)M7-025(17)170119
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 04/05/2019

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: Health Professional
• Device Expiration Date: 01/19/2017
• Device Model Number: CPHV
• Device Catalogue Number: M7-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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: 14 YR