MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS BIOPROSTHESIS; REPLACEMENT HEART VALVE

Model Number	2625
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gradient Increase (1270)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd), a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors, and is not usually an indication of a device malfunction.The device was not returned for evaluation, as it remains implanted.The root cause of this event cannot be conclusively determined.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.
Event or Problem Description
It was reported that a patient with a 27mm aortic porcine valve underwent a valve-in-valve procedure after an implant duration of 22 years, eight (8) months due to aortic stenosis and regurgitation.The tavr was performed with a 26mm transcatheter valve.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections b5, b7, h6 (health effect - clinical code, type of investigation).
Event or Problem Description
It was reported that a patient with a 27mm 2625 aortic porcine valve, implanted in the pulmonic position, underwent a valve-in-valve procedure after an implant duration of 22 years, eight (8) months due to pulmonary stenosis and regurgitation.The tpvr was performed with a 26mm 9600tfx transcatheter valve.There were no complications and the patient tolerated the procedure well.The patient was discharged home on pod #1 in good condition.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections d4 (expiration date).The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.H11: corrected data: corrected section h6 (investigation findings, investigation conclusions).

• Brand Name: CARPENTIER-EDWARDS BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11529515
• Report Number: 2015691-2021-01966
• Device Sequence Number: 5513022
• Product Code: DYE
• UDI-Device Identifier: 00690103021554
• UDI-Public: 00690103021554
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P870056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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: 09/30/2001
• Device Model Number: 2625
• Device Catalogue Number: 262527MM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/25/2021; 04/26/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/23/2021; 04/29/2021
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 48 YR