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

Model Number R5-023

Device Problems Inadequate or Insufficient Training (1643); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/21/2017

Event Type  Injury  

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 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.

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 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
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6946115
• MDR Text Key: 89339355
• Report Number: 3005687633-2017-00100
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012784
• UDI-Public: (01)08022057012784(240)R5-023(17)200726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/26/2020
• Device Model Number: R5-023
• Device Catalogue Number: R5-023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR