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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is in the process of following up to obtain additional information about this event.Device disposition not presently known.
Event or Problem Description
A carbomedics standard valve, size 25, was implanted on (b)(6) 2014 at the mitral position.The valve was explanted on (b)(6) 2018, and replaced with size 27 carbomedics standard.
Additional Manufacturer Narrative
Manufacturer received confirmation that no information is available.
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 unable to obtain further information about this event.As such, the root cause cannot be determined.However, based on the document review performed, no manufacturing deficits were identified.Based on the available information, it is possible that mis-sizing and user error may have contributed to this event, but this cannot be confirmed without further information.

• 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 13040 ; IT 13040
• MDR Report Key: 7492776
• Report Number: 3005687633-2018-00151
• Device Sequence Number: 1339762
• Product Code: LWQ
• UDI-Device Identifier: 08022057012715
• UDI-Public: (01)08022057012715(240)M7-025(17)170821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2018

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: 08/21/2017
• Device Model Number: CPHV
• Device Catalogue Number: M7-025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/25/2018; 06/22/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/21/2018; 06/22/2018
• 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: 47 YR