MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.I. CPHV 31 CARBOMEDICS MECHANICAL VALVE

Model Number	CPHV
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was notified that during a mitral valve replacement a mechanical valve, sz 31 was attempted to be implanted without success.Another size was then implanted sz 29 successfully.
Additional Manufacturer Narrative
Date of this report, corrected data on initial medwatch, initial medwatch inadvertently reported date 01/06/2017 when the date of the report should have been 06/01/2017.No additional information regarding the carbomedics valve was able to be obtained.Based on the size of mechanical valve that was implanted after (size 29 vs 31), it is likely that the cause of the explant was due to oversizing.

• Brand Name: CPHV 31 CARBOMEDICS MECHANICAL VALVE
• Common Device Name: CPHV 31 CARBOMEDICS MECHANICAL VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.I.; via crescentino sn; saluggia, vc
• MDR Report Key: 6606440
• Report Number: 3005687633-2017-00056
• Device Sequence Number: 18972172
• Product Code: LWQ
• UDI-Device Identifier: 08022057012746
• UDI-Public: (01)08022057012746(240)M7-031(17)210226
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

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: 02/26/2021
• Device Model Number: CPHV
• Device Catalogue Number: M7-031
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 08/15/2017
• 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