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

Model Number	3000TFX
Medical Device Problem Codes	Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Through the implant patient registry, it was reported that a patient with a 29mm 3000tfx pulmonary valve implanted for 11 years, 7 months underwent a valve-in-valve procedure due to severe symptomatic pulmonary valve dysfunction.The patient presented with congestive heart failure.The device was replaced with a 29mm 9600tfx transcatheter valve.The patient tolerated the procedure well and was discharged on pod #1 in a stable condition.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.
Additional Manufacturer Narrative
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.Per the instructions for use (ifu), the safety and effectiveness has not been established for children, adolescents, and young adults.This patient was (b)(6) at the initial time of valve implantation.Moreover, this 3000tfx valve is indicated for patient's who require replacement of their native or prosthetic aortic valve.This device was implanted in the pulmonary position.This device has been used in an off-label manner.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
Through the implant patient registry, it was reported that a patient with a 29mm 3000tfx pulmonary valve implanted for 11 years, 7 months underwent a valve-in-valve procedure due to degeneration, severe regurgitation and moderate stenosis.The patient presented with congestive heart failure.The tpvr was performed with a 29mm 9600tfx transcatheter valve.The patient tolerated the procedure well and was discharged on pod #1 in a stable condition.According to the physician, there was no allegation that the surgical valve prematurely failed.
Additional Manufacturer Narrative
H11: corrected data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.

• 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: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 12808219
• Report Number: 2015691-2021-06297
• Device Sequence Number: 17536744
• Product Code: DYE
• UDI-Device Identifier: 00690103163681
• UDI-Public: 00690103163681
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S22
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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
• Report Date (Section B): 12/01/2021

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: 3000TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/13/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male