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

Model Number	2700
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 21mm 2700 valve, implanted in aortic position, is under consideration for a valve-in-valve procedure after an implant duration of 8 years and 7 months due to unknown reason.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: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: updated sections b5, and h6 (type of investigation).
Event or Problem Description
It was reported that a patient with a 21mm 2700 valve, implanted in aortic position, underwent a valve-in-valve procedure after an implant duration of 8 years and 8 months due to unknown reason.The valve was replaced with a 23mm 9750tfx.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: multiple requests for additional information have been performed; however, the healthcare provider has not provided any additional details regarding this event.Although the reason for the valve explant is unknown, there was no indication or allegation of a device malfunction and/or deficiency contributing to the event.The reported event cannot be confirmed with the available information.The root cause of this event remains indeterminable.The subject device was not returned evaluation as it is unknown when/where the device was explanted; therefore, the complaint cannot be confirmed.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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492500222
• MDR Report Key: 19354162
• Report Number: 2015691-2024-03759
• Device Sequence Number: 7703108
• Product Code: DYE
• UDI-Device Identifier: 00690103021592
• UDI-Public: (01)00690103021592(17)180616
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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: 06/16/2018
• Device Model Number: 2700
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/31/2024; 07/01/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/22/2024; 07/03/2024
• Date Device Manufactured: 06/17/2014
• 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: 71 YR
• Patient Sex: Female