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

Model Number 7300TFX

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Rupture (2208)

Event Date 11/14/2023

Event Type  Death  

Manufacturer Narrative

H10: 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.Engineering evaluation summary: an engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and there is no evidence of a product failure with regard to design, reliability, or use error.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.A capa/scar/pra is not required as there are no confirmed product or labeling non-conformances and no other triggers are met.The most likely cause is patient factors, including the poor quality of the patient's tissue.All pertinent information available to edwards lifesciences has been submitted.

Event Description

Through the implant registry, investigation and medical records it was learned a 33 mm 7300tfx mitral valve was explanted at implant due to disruption of the av groove of the mitral annulus due to the rigid ring of the mitral prosthesis and extremely poor quality of the tissues.The valve was replaced with a 31mm 7300tfx valve.The patient expired in operating room.Per information received the 33 mm 7300tfx did not malfunction and there was no deficiency.Per medical record: in or prior to explant of the native mitral valve, the pulmonary artery systolic pressure was 88mmhg and there were bilateral large pleural effusions.The patient underwent clipping of laa.The mitral valve was excessed in its entirety at the level of the noncalcified mitral valve annulus and the subvalvular apparatus removed.A rim of the annular posterior and anterior mitral leaflet was preserved.The tissue integrity noted as poor.It is noted the mitral annulus was grossly enlarged and the annulus significantly larger than the 33mm sizer.A 33mm 7300tfx was implanted.The valve noted to seat well.The patient was weaned from cpb, within a few minutes there was bleeding observed to be filling the pericardial well.On inspection the lateral wall of the lv was bleeding noted to represent a disruption of the av groove of the mitral valve annulus.Cpb was resumed the 33mm 7300tfx was explanted.There was significant disruption of the of the m annulus in the region of p1 and p2.This portion of the mitral annulus was noted as of particularly poor integrity.The disrupted portion of the mitral annulus was repaired with a patch reconstruction.A 31mm 7300tfx implanted.An intraoperative tee confirmed there was no pvl or regurgitation.A new second site of bleeding was soon observed.All attempts to control bleeding were unsuccessful.It is noted in attempting to reconstruct the mitral annulus, which was of extremely poor quality, the rigid ring of the mitral prosthesis was likely the culprit for annular disruption given the extremely poor quality of the tissues in general.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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: 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; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18509782
• MDR Text Key: 332868402
• Report Number: 2015691-2024-00394
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103186291
• UDI-Public: (01)00690103186291(17)241201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7300TFX
• 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
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Female