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

Model Number CPHV

Device Problem Perivalvular Leak (1457)

Patient Problems Endocarditis (1834); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

Unknown device disposition.

Event Description

On (b)(6) 2015, a patient received a carbomedics standard aortic prosthesis a5-023 for streptococcal endocarditis.At five months post procedure, there was evidence of stable moderate peri prosthetic regurgitation.The patient presented with fever and was admitted to the hospital on (b)(6) 2020 requiring metaraminol infusion.The echo/toe showed a borderline dilated left ventricle, hyperdynamic systolic function with moderate to severe prosthetic aortic regurgitation.No obvious vegetation was identified.The blood cultures have been negative and the serology for legionella was positive.The patient has hypoalbuminaemia.The coronary angiogram shows only minor disease.The patient underwent a re-do aortic valve replacement on (b)(6) 2020.The diagnosis was of possible culture negative endocarditis with legionella.The intraoperative findings showed a moderately large peri prosthetic space at the right coronary annulus.The underlying tissue was well healed.The remainder of the valve was extremely well incorporated in the annulus.There was no obvious vegetation or purulent material present.The explanted valve was replaced with a new a5-023.The procedure was completed uneventfully and the outcome was good.

Manufacturer Narrative

A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Since the device was not returned to the manufacturer at the time of explant (and can be reasonably considered as discarded given the time elapsed since the explant), no further investigation is possible at this time.Based on the available information, given that no investigation on the actual device was possible, it is not possible to establish a definitive root cause for the reported event.However, the document review performed, which includes also a review of the sterilization performed at the time of manufacture and release, confirmed the absence of any manufacturing deficiencies on the device involved.Considering that the patient received the cphv valve due to endocarditis and that a stable moderate peri prosthetic regurgitation was visible at 5 months after the procedure, a possible root cause can be traced to the patient's specific baseline conditions.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11891776
• MDR Text Key: 252902821
• Report Number: 3005687633-2021-00127
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012623
• UDI-Public: (01)08022057012623(240)A5-023(17)200306
• 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: 07/21/2021

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: 03/06/2020
• Device Model Number: CPHV
• Device Catalogue Number: A5-023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR