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	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported in a conservative manner due to unknown patient impact.It was clearly stated in the information provided that the event was attributable to mis-sizing.The event root cause is therefore reasonably attributable to user error, and no further investigation is warranted at this time.
Event or Problem Description
A carbomedics standard m7-027 valve was implanted and explanted due to mis-sizing.No other information was reported.
Additional Manufacturer Narrative
The manufacturer received additional information indicating the patient outcome, and confirming that the event was attributable to user error.The original conclusion remains unchanged, and no further investigation is warranted.
Event or Problem Description
A carbomedics standard m7-027 was implanted and explanted intra-operatively on (b)(6) 2018.The device was replaced with a new valve of the correct size.The patient recovered according to expectations, and there was no delay resulting from the event.The event was attributed to user error.

• 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: 7949963
• Report Number: 3005687633-2018-00195
• Device Sequence Number: 940763
• Product Code: LWQ
• UDI-Device Identifier: 08022057012722
• UDI-Public: (01)08022057012722(240)M7-027(17)230323
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/15/2018

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: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: CPHV
• Device Catalogue Number: M7-027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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