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

Model Number CPHV

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/21/2017

Event Type  Injury  

Event 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.

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
• Type of Device: CPHV 31 CARBOMEDICS MECHANICAL VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.I.; via crescentino sn; saluggia, vc
• Manufacturer (Section G): SORIN GROUP ITALY; strada per crescentino sn; saluggia, vc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 60441
• MDR Report Key: 6606440
• MDR Text Key: 76478231
• Report Number: 3005687633-2017-00056
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012746
• UDI-Public: (01)08022057012746(240)M7-031(17)210226
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/26/2021
• Device Model Number: CPHV
• Device Catalogue Number: M7-031
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Date Device Manufactured: 03/29/2016
• 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: 61 YR