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

Model Number CPHV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/11/2018

Event Type  Death  

Manufacturer Narrative

Based on the information received from the site the event is reasonably attributable to the procedure and no device malfunctions have been identified.Because no further information is available and the device will not be received no further investigations will be performed.If further information is received the case will be reassessed.The manufacturer is reporting in a conservative manner due to the young age of the patient at the time of death and the lack of information available.This report regards the patient death two days after implant.A second report has been filed (b)(4) regarding the intra-operative mis-sizing and reoperation.Device not explanted.

Event Description

A patient was diagnosed pulmonary atresia with vsp and received a repair on (b)(6) 2018.Due to complications the patient had 2nd and third surgeries on (b)(6) respectively.On (b)(6) the patient received a carbomedics top hat s5-019 mechanical heart valve (~ etq-2018-05896) and a coronary bypass was performed.Due to issues with the patient's response the s5-019 was explanted and replaced with a smaller carbomedics standard for small annuli a5-016 (~ etq 2018-06564).The patient passed away on (b)(6) 2018.The operations note did not identify the device was available for analysis.Site noted no further information available due to the patient being a minor.This report is in regards to the carbomedics standard for small annuli a5-016.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 7988039
• MDR Text Key: 124478379
• Report Number: 3005687633-2018-00199
• Device Sequence Number: 1
• Product Code: LWQ
• 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
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: A5-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 7 YR