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

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the manufacturer was notified that a carbomedics mechanical valve r5-021 was explanted after 1.48 years on (b)(6) 2017.It was implanted on (b)(6) 2015.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device was performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.A company representative has confirmed that the surgeon would not be providing anymore information on this event and the device was not available for analysis.As such, no further investigation can be performed at this time.Not available for return.

• Brand Name: CARBOMEDICS REDUCED MECHANICAL HEART VALVE
• Common Device Name: CPHV REDUCED
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.I.; via crescentino sn; saluggia, vc
• MDR Report Key: 6593105
• Report Number: 3005687633-2017-00052
• Device Sequence Number: 1148598
• Product Code: LWQ
• UDI-Device Identifier: 08022057012777
• UDI-Public: (01)08022057012777(240)R5-021(17)190816
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: 08/16/2019
• Device Model Number: CPHV
• Device Catalogue Number: R5-021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 10/17/2017
• 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: 67 YR