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

Model Number	CPHV
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Endocarditis (1834); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown device disposition.
Event or Problem 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.
Additional 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
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11891776
• Report Number: 3005687633-2021-00127
• Device Sequence Number: 14243252
• Product Code: LWQ
• UDI-Device Identifier: 08022057012623
• UDI-Public: (01)08022057012623(240)A5-023(17)200306
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR