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

Model Number	6900PTFX
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	03/30/2021
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.Of note, this pericardial mitral valve was initially used off label as it was implanted in the tricuspid position.Per the instructions for use (ifu), "the carpentier-edwards perimount theon mitral pericardial bioprosthesis model 6900ptfx is indicated for patients who require replacement of their native or prosthetic mitral valve." in this case, minimal information regarding this valve-in-valve procedure was received and attempts to obtain additional information regarding the condition of the device, patients medical history, or possible comorbidities have been made.The root cause of this event cannot be determined with the available information.However, this event was most likely impacted by the progression of the patients underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.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.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 learned through the implant patient registry that a patient with a 33mm 6900ptfx valve, implanted in tricuspid position, underwent a valve-in-valve procedure after an implant duration of seven (7) years, six (6) months due to stenosis.The ttvr was performed with a 29mm 9600tfx valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.
Event or Problem Description
Edwards learned through the implant patient registry that a patient with a 33mm 6900ptfx valve, implanted in tricuspid position, underwent a valve-in-valve procedure after an implant duration of seven (7) years, six (6) months due to severe tricuspid regurgitation.The patient presented with chf.A successful ttvr was performed with a 29mm 9600tfx valve.The patient was discharged home in stable condition on pod # 1.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: added additional information to b5, b6 and b7.H11: corrected data: corrected coding to section h6.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.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.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The root cause of this event cannot be conclusively determined with the available information.However, the regurgitation in this case was most likely impacted by the progression of the patients underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Additional Manufacturer Narrative
H11: corrected data: corrected coding to section h6.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11835975
• Report Number: 2015691-2021-03008
• Device Sequence Number: 19580721
• Product Code: DYE
• UDI-Device Identifier: 00690103163629
• UDI-Public: 00690103163629
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• 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): 06/25/2021

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: 09/30/2013
• Device Model Number: 6900PTFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/17/2021; 06/25/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/24/2021; 06/25/2021
• 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: 53 YR