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

Model Number	CPHV
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	02/01/2016
Additional 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 or Problem 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.
Additional 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
• Common Device Name: STANDARD SIZE 31 MITRAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 5479438
• Report Number: 3005687633-2016-00008
• Device Sequence Number: 710898
• Product Code: LWQ
• UDI-Device Identifier: 08022057012746
• UDI-Public: 08022057012746
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2016

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: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/04/2016
• Supplement Report FDA Received Date: 05/06/2016; 10/28/2016
• 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: Hospitalization
• Patient Age: 62 YR