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

Model Number	M7-027
Medical Device Problem Codes	Difficult to Open or Close (2921); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019 a patient received a carbomedics standard mitral valve m7-027 as part of an mvr.The manufacturer was notified that the device was implanted and explanted intra-operatively and replaced with another m7-027.No further information was received.
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.Dhr review has been completed.
Additional Manufacturer Narrative
Additional information was received from the site on sep.11, 2019 identifying the following.The device was not used because a leaflet was not functioning normally.The patient had a normal discharge after use of alternative valve.The device is not available for return or analysis.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.Because the device is not available for return and analysis no further investigations can be performed.The dhr review did not show any elements of device dysfunction or non-conformance.Based on the information presently available the root cause of the reported leaflet dysfunction cannot be established.
Event or Problem Description
On (b)(6) 2019 a patient received a carbomedics standard mitral valve m7-027 as part of an mvr.The manufacturer was notified that the device was implanted and explanted intra-operatively and replaced with another m7-027.No further information was received.Additional information was received from the site on sep.11, 2019 identifying the following.The device was not used because a leaflet was not functioning normally.The patient had a normal discharge after use of alternative valve.The device is not available for return or analysis.

• 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: 8870993
• Report Number: 1718850-2019-01061
• Device Sequence Number: 310985
• Product Code: LWQ
• UDI-Device Identifier: 08022057012722
• UDI-Public: (01)08022057012722(240)M7-027(17)220910
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2019
• Report Date (Section F): 07/10/2019

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: 09/10/2022
• Device Model Number: M7-027
• Device Catalogue Number: CPHV
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2019
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/10/2019; 07/10/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/06/2019; 09/30/2019
• 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: 61 YR