MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS OPTIFORM PROSTHETIC MITRAL HEART VALVE; 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	02/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A carbomedics optiform mitral heart valve was implanted on (b)(6) 2018.Mis-sizing of the valve was identified post-operatively, and immediately explanted and replaced.It was reported that the mis-sizing occurred due to the surgeon's error, and there were no concerns about the usability or functionality of the device.The patient outcome was good.
Additional Manufacturer Narrative
In the initial report, date received by manufacturer was indicated as "mar 2, 2018".This was an error.The date received should have read "(b)(6) 2018", as indicated in this report.
Event or Problem Description
A carbomedics optiform mitral heart valve was implanted on (b)(6) 2018.Mis-sizing of the valve was identified, and immediately explanted and replaced.It was reported that the mis-sizing occurred due to the surgeon's error, and there were no concerns about the usability or functionality of the device.The patient outcome was good.It was not clear from the event description when the mis-sizing was identified.
Additional Manufacturer Narrative
Correction: conflicting information was received from the field regarding when the event occurred.It was originally reported that the event occurred "post-operatively"; however, it is more accurate to report that it was not clear when the mis-sizing was identified.Visual inspection confirmed the presence of suture stitches all around the cuff with some localized areas of damage, reasonably due to removal of the stitches.There were no traces of blood inside the internal fabric layers of the cuff.As such, it appears that the valve was completely implanted, but there is no evidence that the aorta was closed and the patient was taken off bypass.This leads to the conclusion that the procedure was not completed when the mis-sizing was identified.Based on the visual inspection performed, and the event description provided, it is reasonable to conclude that the event was an intra-operative explant and attributable to mis-sizing due to user error, as reported.There was no suspected issue with the device, and no further investigation is warranted at this time.

• Brand Name: CARBOMEDICS OPTIFORM PROSTHETIC MITRAL HEART VALVE
• 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: 7491021
• Report Number: 3005687633-2018-00147
• Device Sequence Number: 239035
• Product Code: LWQ
• UDI-Device Identifier: 08022057012722
• UDI-Public: (01)08022057012722(240)M7-027(17)220626
• 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 Implanted Year: 2018
• 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): 06/01/2018

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: 06/26/2022
• Device Model Number: CPHV
• Device Catalogue Number: M7-027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 04/13/2018; 05/22/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/07/2018; 06/01/2018
• 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