MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE

Model Number A5-021

Device Problem Insufficient Information (3190)

Patient Problem Stroke/CVA (1770)

Event Date 08/29/2014

Event Type  Injury  

Manufacturer Narrative

Based on clinical experience, a mechanical prosthetic valve is not prone to calcification, thus it is likely that the calcium originated from deposits on the patient's anatomical structures, and not on the device.Despite the echo reports received refer to possible stenosis of the prosthesis, no device malfunctions were reportedly identified before the event, and the device remains implanted up to date.Thus, there is not sufficient evidence to reasonably deem the event related to the device.However, since no investigation is possible (device not explanted) and since there is not sufficient information to assess the device functionality over time, it is not possible to establish a definitive root cause for the reported event.Device remains implanted.

Event Description

The manufacturer received information that a patient who received a carbomedics standard aortic implanted on (b)(6) 1990, experienced a stroke on (b)(6) 2014.It was reported that the cause of the cerebrovascular accident was identified in a calcium deposit that embolized from the aortic valve.The results of the brain-mri showed that the calcium was successfully removed.As confirmed by the physician, the device seemed to be working fine before the event, and the device is still presently implanted, with no malfunction/serious injury identified since 2014.Data shared on the device functionality at the time of the event ((b)(6) 2014) showed a well seated mechanical prosthetic valve, without regurgitation and possible stenosis (mean gradient 31.4mmhg).The echo performed in (b)(6) 2016 referred to possible stenosis (mean gradient 31.4mmhg).Trivial regurgitation was also identified at this time.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9851307
• MDR Text Key: 191914490
• Report Number: 3005687633-2020-00108
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/1991
• Device Model Number: A5-021
• Device Catalogue Number: A5-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability