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

Model Number	R5-023
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported in a conservative manner as limited information is known to date.The manufacturer is in the process of determine further details on the event from the physician.Device not returned.
Event or Problem Description
The manufacturer was notified through patient tracking of a carbomedics reduced aortic valve r5-23 (size 23) model r500 that was implanted/explanted.The device was discarded.
Additional Manufacturer Narrative
Updated fields: date of report, event description (updated), date received by manufacturer, type of report, type of follow-up, event codes (updated).Follow-up with sales revealed that the event was related to a training gap.Please note: this event occurred subsequent to a second adverse event (failure to implant) which is being reported in a second emdr.
Event or Problem Description
The manufacturer was notified through patient tracking of the following event: on (b)(6) 2017, a failure to implant occurred.Following this, an attempt was made to implant a carbomedics reduced aortic valve, r5-23 (size 23) model r500.The valve was placed upside-down in the mitral position, and was subsequently explanted.No information is available regarding replacement of the explanted device.The patient concomitantly received a tricuspid ring.Follow-up with sales revealed that the event occurred due to inadequate proctoring regarding the device in question.

• Brand Name: CARBOMEDICS REDUCED
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia 13040 ; IT 13040
• MDR Report Key: 6946115
• Report Number: 3005687633-2017-00100
• Device Sequence Number: 13623924
• Product Code: LWQ
• UDI-Device Identifier: 08022057012784
• UDI-Public: (01)08022057012784(240)R5-023(17)200726
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 07/26/2020
• Device Model Number: R5-023
• Device Catalogue Number: R5-023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: 44 YR