MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. SORIN BIOPROSTHETIC AORTIC VALVE 21MM; HEART - VALVE, MECHANICAL

Catalog Number DLA21

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Death (1802)

Event Date 03/05/2018

Event Type  Injury  

Event Description

October 1, 2018 we were notified that the pt was returned to surgery on (b)(6) 2018 to replace the sorin valve implanted on (b)(6) 2015, due to prosthetic aortic stenosis and calcification.Pt expired on (b)(6) 2018.

• Brand Name: SORIN BIOPROSTHETIC AORTIC VALVE 21MM
• Type of Device: HEART - VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.
• MDR Report Key: 7990179
• MDR Text Key: 124669881
• Report Number: MW5080715
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Weight: 115