MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX23A

Device Problem Device-Device Incompatibility (2919)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/30/2022

Event Type  Death  

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 23 mm sapien 3 ultra valve in the native aortic valve via transfemoral approach.Patient is a risk for left main (lm) occlusion due to effaced sinuses.A non-ew stent was parked in the left coronary artery (lca) on a run through intervention wire.This stent and wire was through a guide catheter which was backed out of the lm.The 23 mm sapien 3 ultra valve was deployed in an 80/20 position and the patient's blood pressure did not recover.An attempt to re-engage the lm and retract the stent back to the lm from further distal in the lca.The wire was pinned behind the thv stent frame and was unable to easily retract the stent into position.After pulling more firmly the stent balloon broke and dislodged from the stent.The balloon was removed from the guide catheter and to try to re-wire down the lm but was unable to get any wire or balloon up the guide catheter.The delivery system was removed.A different guide catheter was placed through the esheath in an attempt to send a wire down the lm and pass a balloon next to the original stent that was trapped in the lm in order to try and "crush" it against the coronary wall.The guide catheter was unable to pass down the left main.The patient expired.

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 component codes and investigation conclusions.Added new information to h.6 type of investigation and investigation findings.The sapien 3 ultra valve was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and no device malfunction or difficulty contributed to the occlusion harm, including the commander delivery system, the ew inflation balloon, and the sapien 3 ultra valve.The complaint was unable to be confirmed due to unavailability of relevant procedural imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.As reported, ''during the procedure of a 23 mm sapien 3 ultra valve in the native aortic valve via transfemoral approach.The patient is a risk for left main (lm) occlusion due to effaced sinuses.A non-ew stent was parked in the left coronary artery (lca) on a run through intervention wire.This stent and wire were through a guide catheter which was backed out of the lm.The 23 mm sapien 3 ultra valve was deployed in an 80/20 position and the patient's blood pressure did not recover.An attempt to re-engage the lm and retract the stent back to the lm from further distal in the lca.The wire was pinned behind the thv stent frame and was unable to easily retract the stent into position.After pulling more firmly the stent balloon broke and dislodged from the stent''.In this case, a non-ew stent was parked at left coronary artery through the intervention wire prior ew sapien 3 ultra valve was deployed.If the intervention wire was not properly retracted from the native annulus, which could lead the intervention wire ''pinned behind the thv stent frame'' or trap between the frame and native annulus.As such, available information suggests that procedural factors (improper retracted intervention wire with non-ew stent prior thv deployment) may have contributed to the complaint event.However, a definitive root cause was unable to be determined.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14190457
• MDR Text Key: 289948448
• Report Number: 2015691-2022-05380
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)230824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: 9750TFX23A
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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 Sex: Female