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

Model Number	3300TFXJ21
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.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.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular regurgitation and/or stenosis.In this case, minimal information regarding this valve replacement procedure was received and attempts to obtain additional information regarding the condition of the device, patient's 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 patient¿s underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The device was not returned for evaluation.If returned and evaluated a supplemental report with findings will be submitted.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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.If new information becomes available, a supplemental report will be submitted.
Event or Problem Description
Edwards received information through its implant patient registry that a 21mm 3300tfx aortic pericardial valve was explanted after a duration of four (4) year and eleven (11) months due to unknown reason.A 21mm 11500aj aortic valve was implanted in replacement.There was no allegation of device malfunction.It was unknown if the device will be returned at this time.
Event or Problem Description
Edwards received information through its implant patient registry that a 21mm 3300tfx aortic pericardial valve was explanted after a duration of four (4) year and eleven (11) months due to hardened leaflets.A 21mm 11500aj aortic valve was implanted in replacement.There was no allegation of device malfunction.The device was not returned for evaluation as it was discarded at the hospital.
Additional Manufacturer Narrative
Updated: b5, e1, f10, h6, h10.H10: additional manufacturer narrative: bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.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.The root cause of this event cannot be conclusively determined with the available information.However, the degeneration exhibited by the bioprosthetic valve in this case was most likely impacted by the progression of the patient¿s underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The subject device cannot be returned for evaluation as it was discarded.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.
Additional Manufacturer Narrative
Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10214249
• Report Number: 2015691-2020-12359
• Device Sequence Number: 3270684
• Product Code: DYE
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P860057/S042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2020

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: 07/01/2018
• Device Model Number: 3300TFXJ21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 07/23/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/27/2020; 12/08/2020
• 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; Required Intervention
• Patient Age: 79 YR