MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/13/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not received.A change in size indicates mis-sizing but because the device cannot be evaluated the root cause can not be determined.Device not received.
Event or Problem Description
Information from backlog of international prfs we received 2nd prf a5-021 for patient with a5-023 at same position.Details are as following: first, a5-023 sn # (b)(4) was implanted on (b)(6) 2015 at aortic position.Second, a5-021 sn # (b)(4) was implanted on (b)(6) 2015 at same position.
Additional Manufacturer Narrative
Follow-up to clarify event was a result of mis-sizing.
Event or Problem Description
Confirmation that event was attributed to mis-sizing.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7291139
• Report Number: 3005687633-2018-00116
• Device Sequence Number: 19395278
• Product Code: LWQ
• UDI-Device Identifier: 08022057012623
• UDI-Public: (01)08022057012623(240)A5-023(17)191115
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 11/15/2019
• Device Model Number: CPHV
• Device Catalogue Number: A5-023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 02/23/2018
• 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; Required Intervention
• Patient Age: 42 YR