MAUDE Adverse Event Report: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS

Model Number	A5-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device being sent to manufacturer.
Event or Problem Description
On (b)(6) 2018 a patient received a carbomedics standard a5-016 mechanical heart valve implant.During the post-operative echocardiography the site noticed a leakage.The valve was explanted and replaced with a r5-019 carbomedics reduced aortic valve on (b)(6) 2018.
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.The device was returned to the manufacturer on jan.25, 2019.A gross inspection was performed on the returned device.The returned material was received in the original carton box that was slightly wet and with traces of mold.The valve itself was contained in a plastic jar for specimen and appeared in general good conditions.The manufacturer received additional follow-up from the site stating they were not able to provide any further information.
Additional Manufacturer Narrative
The returned valve was received in the original carton box, slightly wet and stained, and inserted in a plastic jar for specimen; the valve itself appeared in general good conditions.After decontamination the valve was visually inspected observing only few signs of stitching and in general no other anomalies.Then the valve was cleaned and the sewing cuff was removed.The visual assessment on the sub-assembly, performed by qc personnel, did not highlight any macroscopic anomalies.The hydrodynamic testing conducted on the cphv sub-assembly, size 16 ¿ (b)(4) was performed using the r0187 - vivitro pulse duplicator equipment.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean aortic pressure of 100 mmhg is 1.05 cm2, above the iso 5840 minimum requirement of 0.85 cm2 for the valve #19.For a cardiac output of 5.0 l/min and mean aortic pressure of 100 mmhg, the regurgitant fraction [%] is 8.8% and it is below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent tad.The valve showed a correct movement of the leaflets during opening and closure phases.No anomalies were observed in hypotensive conditions.The result of the device history record review of the returned cphv prosthesis sn (b)(4) confirmed that the returned product satisfied all material, dimensional and performance standards, required for a carbomedics standard aortic a5-016 at the time of manufacture and release, including the function test of the valve in a hydrodynamic tester.Based on the performed analysis, the reported issue is not related to the device quality because the claimed leakage was not observed.The root cause of the reported leakage is thus unknown and cannot be established.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• MDR Report Key: 8098901
• Report Number: 3005687633-2018-00218
• Device Sequence Number: 1913516
• Product Code: LWQ
• UDI-Device Identifier: 08022057012586
• UDI-Public: (01)08022057012586(240)A5-016(17)230402
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2019

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: 04/02/2023
• Device Model Number: A5-016
• Device Catalogue Number: A5-016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/25/2019; 02/22/2019
• Initial Report FDA Received Date: 11/22/2018
• Supplement Report FDA Received Date: 02/21/2019; 02/22/2019
• 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: 77 YR