MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART VALVE, MECHANICAL

Model Number CP-021

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/20/2020

Event Type  Death  

Manufacturer Narrative

Based on the information received, the patient's ultimately passed away after the re-do surgery.Although no evidence of device malfunctions are reported and the pre-operative conditions highlighted that the patient was at high risk for a re-do surgery, the manufacturer is reporting this event in a conservative manner.The manufacturer has submitted a second report for this event ((b)(4)) for the mitroflow dla valve explanted at the time of the carboseal device implant.Further investigation is ongoing and an update will be provided to this reporting activity once completed.

Event Description

On (b)(6) 2020, a patient underwent a re-do aortic valve replacement to explant a degenerated mitroflow valve ((b)(4)) and received a carboseal valsalva cp-021.A right common femoral artery balloon pump and a right swan-ganz catheter were placed at the time of the re-do procedure.The patient was moved to the icu in critical conditions.The patient slowly deteriorated on pod1 requiring more inotropic support and ventilator support.The patient passed away on (b)(6) 2020.

Manufacturer Narrative

Fields updated: b4, b5, f6, f7, f10.Since no autopsy was performed, the device remains implanted in the patient and no investigation on the device is possible.Based on the available information and medical judgment received, the device was excluded as contributory cause to the event.No malfunctions were reportedly identified.Thus, the root cause of the reported event is not attributable to the carboseal valsalva cp-021 and no further investigation is warranted at this time.

Event Description

Based on the additional information received from the hospital, there was no autopsy performed.No malfunctions were identified in the cp-21, which was reportedly not suspected as contributory cause to the patient's death.The remainder of the information remains the same as previously submitted.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 11068730
• MDR Text Key: 223577501
• Report Number: 1718850-2020-01229
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013538
• UDI-Public: (01)08022057013538(240)CP-021(17)220501
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/24/2020,01/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: CP-021
• Device Catalogue Number: CP-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR