MAUDE Adverse Event Report: SORIN GROUP ITALIA, S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number CPHV

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

Patient Problems Death (1802); Rupture (2208)

Event Date 02/10/2018

Event Type  Death  

Manufacturer Narrative

Based on the information received, the event is attributable to the patient's anatomy, including fragile tissue and a small aortic root.As such, no device deficiency is suspected and no investigation is warranted at this time.Device not explanted.

Event Description

A carbomedics prosthetic heart valve was implanted on (b)(6) 2018.It was reported that the patient had very fragile vasculature and abnormal anatomy.The aortic root was very small and could not accommodate a 19 mm valve.A root enlargement was performed, and a 21 mm valve was implanted, but was still very tight.The patient was weaned from pump easily; however, after administering protamine the patient's tissue tore due to the tissue fragility.Bypass was restarted, and a the tear was fixed with a large patch, but it was not possible to wean the patient off pump despite administering iabp, flolan and maximum doses of multiple other drugs.The patient passed away in the operating room.The valve was not excised after death.The patient's death was attributed to a combination of patient factors, including a small aortic root and fragile tissue, and the use of a bulky, rigid mechanical valve.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• 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; strada crescentino snc; saluggia, vc 13040 ; IO 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 7353980
• MDR Text Key: 102937927
• Report Number: 3005687633-2018-00128
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)220818
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/18/2022
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 54 YR