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

Model Number	2700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned 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.
Event or Problem Description
It was reported that a patient with a 25mm aortic valve underwent a valve-in-valve procedure after an implant duration of 8 years, 1 month due to regurgitation.The patient presented shortness of breath with exertion.The procedure was performed with a 26mm transcatheter valve.The procedure was successful and the patient was sent to recovery post-procedure.
Additional Manufacturer Narrative
H10: additional narratives: the most likely cause is patient factors, including a history of hld.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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 a patient with a 25mm 2700 aortic valve underwent a valve-in-valve procedure after an implant duration of 8 years, 1 month due to severe regurgitation.The patient presented with nyha ii, shortness of breath with exertion, and fatigue.The procedure was performed with a 26mm 9750tfx transcatheter valve.The procedure was successful and the patient was sent to recovery post-procedure.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
• 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: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16977783
• Report Number: 2015691-2023-13156
• Device Sequence Number: 17762412
• Product Code: DYE
• UDI-Device Identifier: 00690103021615
• UDI-Public: (01)00690103021615(17)181019
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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: 10/19/2018
• Device Model Number: 2700
• Device Catalogue Number: 270025MM
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 05/19/2023; 07/03/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/13/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male