MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX; REPLACEMENT HEART-VALVE

Model Number	2700TFX
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation as it remains implanted.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 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 this patient with a 2700tfx 23mm aortic valve implanted for five (5) years and 11 months, is being evaluated for valve-in-valve procedures due to stenosis.
Additional Manufacturer Narrative
H10.Additional manufacturer narrative: added information to b5, b6, b7, h6.
Event or Problem Description
It was reported that this patient with a 7300tfx 31mm mitral valve, implanted for five (5) years and 11 months, is being evaluated for valve-in-valve procedure due to severe mitral stenosis.Patient was admitted to hospital for acute exacerbation of congestive heart failure.Patient was treated with inotropic assisted diuresis and placed on guideline directed medical therapy involving medications.Tee during admission showed moderate aortic stenosis and severe mitral stenosis with worsening gradients.Physician recommended the patient for tmvr to treat the patient's worsening mitral stenosis.No tmvr has been scheduled.No indication.
Additional Manufacturer Narrative
Corrected data: corrected b5.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
Edwards received information a patient with a 23mm 2700tfx aortic valve implanted five (5) years, 11 months, was being evaluated for valve-in-valve procedure due to moderate aortic stenosis.The patient was admitted for acute exacerbation of congestive heart failure and was medically treated and discharged home.Tee during admission showed moderate aortic stenosis and severe mitral stenosis with worsening gradients and tmvr was recommended.Tmvr has not been scheduled as the patient declined, states he feels extremely well and wants to continue medical management.There was no indication or plans for intervention for the aortic valve.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15572794
• Report Number: 2015691-2022-08465
• Device Sequence Number: 2821811
• Product Code: DYE
• UDI-Device Identifier: 00690103194036
• UDI-Public: (01)00690103194036(17)200622
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/14/2022

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: 2700TFX
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 10/09/2022; 11/11/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 11/03/2022; 11/14/2022
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male