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

Model Number	6625
Medical Device Problem Codes	Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: stenosis and/or regurgitation, 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.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis and regurgitation in this case were most likely impacted by the progression of the patient's underlying valvular disease pathology with structural valve deterioration.The subject device is not available for evaluation, as it remains implanted in the patient.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.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
Edwards received notification that this patient with a 25mm 6625 mitral valve underwent a valve-in-valve procedure after an implant duration of approximately 11 years due to degeneration leading to severe mitral stenosis and moderate mitral regurgitation.As reported, the patient presented with intermittent asthmatic suffocation during activities, incapability to supine after waking up at night, reduced activity tolerance, cough pink foam sputum.After walking 200 meters asthmatic suffocation symptoms appeared.No chest pain, no dizziness, no headache, no palpitations, no perspiration, no blackness or syncope.This patient was a high risk for re-do mvr (sts 13.564%) and frailty (induced by open chest surgery and blood loss).A sapien 3 transcatheter valve was implanted in replacement.After implanting a sapien 3 valve with a good position and gradient, immediately the blood pressure decrease and s-t segment elevate.Echo diagnosis showed pericardial effusion and developed into cardiac tamponade.Open chest surgery was performed to deal with pericardial effusion.The blood was stopped; vital signs were stable.The pericardial effusion was induced by support wire perforation.At last, the patient was alive at the end of procedure and transferred to ccu.The patient expired late at night.There was no allegation for edwards device caused or contributed to the patient's death.
Additional Manufacturer Narrative
H11: corrected data: corrected sections h6 (investigation findings, investigation conclusions).

• Brand Name: CARPENTIER-EDWARDS BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11373755
• Report Number: 2015691-2021-01420
• Device Sequence Number: 11705785
• Product Code: DYE
• UDI-Device Identifier: 00690103021936
• UDI-Public: 00690103021936
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P870056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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 Model Number: 6625
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/01/2021
• 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: 81 YR
• Patient Weight: 40