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

Model Number TBD

Device Problems Gradient Increase (1270); Material Too Rigid or Stiff (1544)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

Device not explanted.

Event Description

In (b)(6) 2016 a patient received a carbomedics aortic mechanical valve, size 19.The manufacturer was notified that during the patients follow-up (approx.(b)(6) 2018) lv systolic function is within normal limits, but the echo doppler gradient across the aortic valve has increased, now pipg 52, mean 25 mm hg.On (b)(6) 2019 the manufacturer was notified echo shows a minimal increase in doppler gradient (pipg 55, mean 32, compared to six months ago pipg 52, mean 25), with normal lv size and function.They also identified the posterior leaflet was not moving normally, suspected by echo, and confirmed by fluoroscopy.His inr is 1.9.The child is not meeting criteria for surgical reop on his aortic valve per site decision.

Manufacturer Narrative

Based on the information received the patient symptoms are being monitored and the root cause of the reported increased gradient cannot be confirmed.The leaflet functionality decrease identified is also being monitored but does not presently meet criteria for reoperation.The patient will continue to be monitored and if any further information is received the investigation will be reassessed.

• 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
• MDR Report Key: 8698007
• MDR Text Key: 147999703
• Report Number: 3005687633-2019-00207
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 7 YR