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

Model Number CP-029

Device Problem Gradient Increase (1270)

Patient Problems Aortic Valve Stenosis (1717); Death (1802); Thrombus (2101)

Event Date 11/21/2018

Event Type  Death  

Manufacturer Narrative

Device not explanted.

Event Description

On (b)(6) 2018 a patient received a carboseal valsalva to treat moderate aortic stenosis.Eventless procedure and postoperative course until after extubation.Then patient collapses while being taken to icu nurse, and went into was cardiac arrest.Resusitation and reoperation incl.Ecc and opening of tube graft.Thrombus around both coronaries buttons was found and when given retrograde cardioplegia, thrombus came out of left main stem.Closed the graft again weaned from ecc and returned to icu.On (b)(6) 2018 ct scan revealing two large ischemic areas in right and left cerebral hemispheres with surrounding bleeding.Therapy ceased.The patient died on (b)(6) 2018.The hospital theorize that the event may have been due to a hypercoagulation defect.

Manufacturer Narrative

The manufacturing and material records for the carboseal valsalva ascending aortic prosthesis, model # cp-029, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer.The results confirmed that this valve satisfied all material, visual, and performance standards required for a cp-029 carboseal valsalva ascending aortic prosthesis at the time of manufacture and release.The manufacturer has made several attempts to follow-up for additional information and was not able to obtain further event information.Because the device was not available for return and analysis no additional investigations can be performed by the manufacturer and the root cause of the reported event cannot be determined.The hospital theorized that the patient's condition, specifically a possible hyper-coagulation defect, may have contributed to the reported event.Based on the information available regarding the reported adverse event, and because the device is not available for analysis, the manufacturer is unable to provide a response regarding the suspected hypercoagulation defect reported by the site.The rationale for the sites hypothesis was not provided to the manufacturer.

• 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, vc
• MDR Report Key: 8182316
• MDR Text Key: 130969304
• Report Number: 3005687633-2018-00237
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: CP-029
• Device Catalogue Number: CP-029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR