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

Model Number	3000
Medical Device Problem Codes	Degraded (1153); Gradient Increase (1270)
Health Effect - Clinical Codes	Dyspnea (1816); Irregular Pulse (2469); Insufficient Information (4580)
Date of Event	08/25/2021
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) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, the nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The subject device is not available for evaluation as it remains implanted in the patient.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
It was reported that a patient with a 27mm 3000 pericardial valve, implanted in the aortic position, underwent a valve-in-valve procedure after an implant duration of nine (9) years, eight (8) months due to stenosis.The tavr was performed with a 26mm 9750tfx transcatheter valve with no complications.No additional information has been provided.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: the device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.
Additional Manufacturer Narrative
Updated b5, b7, and h6 per new information.
Event or Problem Description
It was reported that a patient with a 27mm 3000 pericardial valve, implanted in the aortic position, underwent a valve-in-valve procedure after an implant duration of nine (9) years, eight (8) months due to symptomatic severe stenosis (mean gradient 44mmhg) and degeneration.The patient presented 29 week pregnant with palpitations and dyspnea.A tavr was performed with a 26mm 9750tfx valve with no complications.Post-tavr echocardiogram revealed a mean aortic valve gradient of 17 mmhg without ai.Patient was discharged 24 hours post-procedure.Per literature review of tavr beyond fetal viability an alternative to preterm delivery in symptomatic severe aortic stenosis: this is the first reported tavr in 3rd trimester.Post taviv, the patient underwent an uncomplicate primary cesarean section(breech) at term.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12478744
• Report Number: 2015691-2021-05202
• Device Sequence Number: 17127652
• Product Code: DYE
• UDI-Device Identifier: 00690103162271
• UDI-Public: 00690103162271
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2024

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: 03/25/2013
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 11/02/2021; 05/13/2024
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/04/2021; 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female