MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS CERTITUDE DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9620TA29

Device Problems Difficult to Advance (2920); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in (b)(6), during a trans-aortic transcatheter aortic valve replacement (tavr) with a 29mm sapien 3 valve, during insertion, there was resistance with the valve through the sheath.Once the valve was advanced trough the sheath, the valve was not in between the alignment markers.The decision was to inflate the device and deploy the valve.The valve embolized into the aorta and was deployed in the descending aorta, above the renal arteries.The patient will receive a new valve surgically.

Manufacturer Narrative

Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to aortic embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified aortic leaflets, preserved ejection fraction, loss of pacing capture, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.The delivery system was not returned to edwards lifesciences for evaluation.A review of imagery provided showed the following: prior to valve deployment, the valve was not between the proximal and distal shoulders.It appeared to be over the proximal shoulder.The overall crimped valve profile (yellow dotted lines) appeared to be relatively larger than the distal and proximal shoulders' ods (blue arrows).As the balloon inflated, the valve was partially expanded in the distal end and pushed back proximally over the steering tube.The valve was finally deployed in the descending aorta.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed no additional similar complaints relating to resistance and valve movement on balloon.A review of the complaint history from september 2020 to august 2021 revealed additional similar complaints for resistance and thv moves on balloon for certitude delivery system (all models and sizes).The complaints were confirmed, but no manufacturing non-conformities that would have contributed to the reported events were identified.Available information suggested that patient and/or procedural factors may have contributed to the complaint events.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.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaints for thv moves on balloon and resistance were confirmed by the provided imagery.A review of dhr, lot history, and complaint history review did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.Per report, ''when physician inserted the valve in the sheath, it was not very easy and, once the valve was out of the sheath and into the aorta, the valve was not perfectly between the two shoulders of the balloon, it was too high.'' per the training manual, ''high push force through the sheath may be experienced.Use short movements when advancing delivery system.'' procedural factors such as high insertion angle, improper crimping, or improper flushing can contribute to resistance with the delivery system when advancing through the sheath.The provided imagery reveals the crimped valve profile appeared to be relatively larger than the distal and proximal shoulders outer diameter.Such is indicative of improper crimping.A larger than normal crimped valve could increase the interaction with the sheath during advancing the delivery system through leading the reported difficulty.As the valve was increasingly rubbed against the sheath wall during forward push force, this interaction could cause the valve to be shifted towards the proximal direction leading to the reported valve movement.Furthermore, if high push force was used to advance the delivery system through the sheath, it is possible that the valve moved proximally off the working length during insertion.As the provided imagery revealed that the valve was over the proximal shoulder prior to valve deployment.The valve moved further proximally as the balloon inflated.Without the return of the complaint device, there is insufficient information to determine a root cause.However, available information suggests that procedural factors (improper crimping, high push force) likely contributed to the reported events.Since no product non-conformances or ifu/training manual deficiencies were identified, a product risk assessment escalation and corrective/preventative actions are not required.

• Brand Name: EDWARDS CERTITUDE DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12415497
• MDR Text Key: 270667766
• Report Number: 2015691-2021-04977
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2022
• Device Model Number: 9620TA29
• Device Catalogue Number: N/A
• Device Lot Number: 63310671
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention