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

Model Number	2700TFX
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Chest Pain (1776); Insufficient Information (4580)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was learned from implant patient registry that a model 2700tfx 29mm aortic valve was explanted and replaced with a 11060a 25mm valve after an implant duration of 7 years, 4 months due to unknown reasons.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.
Event or Problem Description
It was learned from implant patient registry and investigation that a model 2700tfx 29mm aortic valve was explanted after an implant duration of 7 years, 4 months to repair aortic root aneurysm.The patient was presented with chest pain.The explanted valve was replaced with a 25mm 11060a aortic valved conduit.The patient was stable at the end of the procedure.
Additional Manufacturer Narrative
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.Per drm (b)(4), rev d, on occasion the device may be explanted with no evidence of malfunction and is otherwise performing as intended.Such as for aortic graft replacement, to enlarge aortic root, repair fistula, control bleeding/coagulopathy or other non-device related reason.In these events, the device may require removal to control bleeding or to facilitate repair of the injury.The event is not related to the device.A definitive root cause is unable to be determined, however patient factors likely caused or contributed.H11: corrective 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 THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16981777
• Report Number: 2015691-2023-13167
• Device Sequence Number: 6693496
• Product Code: DYE
• UDI-Device Identifier: 00690103177213
• UDI-Public: (01)00690103177213(17)170505
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2023

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: 05/05/2017
• Device Model Number: 2700TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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