MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	8300AB
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Through implant patient registry it was learned that a 27mm 8300ab valve was explanted after an implant duration of 3 years, 17 days due to unknown reason.The explanted valve was replaced with a 29mm 3300tfx valve.The patient was in recovery post procedure.
Additional Manufacturer Narrative
Additional manufacturer narrative: the subject device is not available for evaluation, as the device status is unknown.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.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: h11: corrective data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
Through implant patient registry it was learned that a 27mm 8300ab valve was explanted after an implant duration of 3 years, 17 days due to prophylactic purpose.The patient presented with shortness of breath.The explanted valve was replaced with a 29mm 3300tfx valve.The patient was in recovery post procedure.Per the information received the reason for the intervention was the repair of an aorta to right atrial fistula.

• Brand Name: EDWARDS INTUITY ELITE AORTIC VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15596729
• Report Number: 2015691-2022-08561
• Device Sequence Number: 2277853
• Product Code: LWR
• UDI-Device Identifier: 00690103194517
• UDI-Public: (01)00690103194517(17)220603
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 8300AB
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 11/09/2022
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Male