MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD; STANDARD SIZE 31 MITRAL

Model Number CPHV

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983); Device Handling Problem (3265)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/01/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Device history record review and mechanical evaluation of the device is ongoing.The returned device was received with a leaflet broken.The breakage of the leaflet occurred during implantation.As per preliminary inspection on the as received device, the leaflet still in position was freely moving.Possible mishandling to be further investigated.

Event Description

The company was notified on (b)(6) 2016 about an issue related to a carbomedics standard mitral valve (model m7-031, serial # (b)(4)).On (b)(6) 2016, p.S.((b)(4)) (b)(6) male patient, implanted the valve above mentioned.This valve was implanted and it was then observed that one of the leaflets was stuck and wouldn't open.That valve was explanted and another mitral valve was implanted.

Manufacturer Narrative

Initial comments: the returned device was received with a leaflet broken.The breakage of the leaflet occurred during implantation.As per preliminary inspection on the as received device, the leaflet still in position was freely moving.Possible mishandling to be further investigated.Follow up: investigation confirmed the mishandling as cause of leaflet breakage.

• Brand Name: CARBOMEDICS STANDARD
• Type of Device: STANDARD SIZE 31 MITRAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: giovanni bergamasco ; via crescentino sn; saluggia, vc 13040 ; IT 13040 ; 9161487034
• MDR Report Key: 5479438
• MDR Text Key: 39633169
• Report Number: 3005687633-2016-00008
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012746
• UDI-Public: 08022057012746
• 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: Nursing Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2020
• Device Model Number: CPHV
• Device Catalogue Number: M7-031
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• 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): Hospitalization
• Patient Age: 62 YR