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

Model Number 9600LDS26A

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Material Rupture (1546); Failure to Align (2522); Material Split, Cut or Torn (4008)

Patient Problems Death (1802); Injury (2348); Blood Loss (2597)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is one of two manufacturer reports being submitted for this case.Investigation is ongoing.

Event Description

During the valve alignment of the sapien 3 onto the commander delivery system via left subclavian axillary access, there was difficulty with valve alignment.It was attempted to align the valve in the esheath, as it was the straightest section.However, it could not be completed in the esheath, so the valve was pushed outside of the sheath, but could not be completely aligned.The team decided to deploy with the valve 80% aligned onto the balloon.However, the balloon would not inflate.It is believed it "ruptured" during the difficulty with valve alignment.During retrieval of the valve into the sheath, it was seen that the esheath seam had ¿torn¿, but the valve and delivery system were able to be pulled into the sheath.It was seen that the pusher was not all the away against the valve, so it had to be re-advanced, then pulled it.There was not much difficulty pulling the delivery system into the sheath.During removal, the esheath ¿pulled the artery out¿.The balloon was kept in the subclavian artery to block the blood loss, as the patient had loss ¿2 liters¿ already.Due to the injury at the access site, the patient was converted to surgery and a covered stent was placed in the proximal subclavian artery.  unfortunately, there was too much blood loss and the patient passed away.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded by the site.No relevant imagery of the complaint device was provided from the site.A lot history review revealed no other similar complaints.A device history records (dhr) review did not reveal any issues that could have contributed to this complaint event.A review of the complaint history of the past 12 months from the complaint initiation date, from (b)(6) 2018 to (b)(6) 2019, revealed other returned complaints for delivery system ¿ difficulty with valve alignment and balloon - torn (all models).No manufacturing non-conformances that would have contributed to the complaints were identified during these evaluations.Available information suggest that patient and/or procedural factors may have contributed to the similar complaints for difficulty with valve alignment.  available information suggested that the tears may have occurred during valve alignment and could be attributed to patient/procedural factors.Due to the high criticality level for this failure mode, a product risk assessment was previously done for risk assessment.A review of the complaint history revealed that the occurrence rate did not exceed the control limit for the trend categories.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint event.Commander ifu, device preparation manual, procedural training manual, and subclavian training manual were reviewed for instructions/guidance on device preparation/usage.No ifu/training deficiencies were identified.Due to lack of relevant imagery, the complaints were unable to be confirmed.Due to unavailability of device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be confirmed.As valve alignment could not be done in a straight section, it is likely there was alignment difficulty and high forces on the area near the inflation balloon to crimp balloon bond.The thv may unseat (non-coaxial placement of the thv in relation to the flex tip) from the flex tip and ¿dive¿ into the lumen of the flex tip if bends/angles are present during valve alignment.This can also result in higher than usual alignment forces, weakening and subsequently tearing the balloon material.Under simulated conditions (tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces with valve diving.Although a definitive root cause is unable to be definitively determined; available information suggests that patient (tortuosity) and/or procedural (valve alignment in non- straight section of vasculature/ high alignment forces) factors may have contributed to the complaint events.Since applicable devices were not returned, it cannot be determined if a manufacturing non-conformance contributed to the complaint event.However, a review of lot history, complaint history and manufacturing mitigations revealed that it is unlikely a manufacturing issue contributed to the complaint.Additionally, a review of ifu/training manuals revealed no deficiencies.Per management discretion, the balloon torn issue and it associated risks have previously been assessed and documented in a product risk assessment done by edwards. edwards has included additional information that currently exists in the training manuals, into the ifu ¿instructions for use¿ for the sapien 3 and commander delivery system as part of a capa previously opened.Review of complaint history revealed that the occurrence rate did not exceed the control limit for the applicable trend categories.Since no manufacturing non-conformances, labeling, training, or ifu deficiencies were identified, no corrective and preventative action is required at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8720402
• MDR Text Key: 148797977
• Report Number: 2015691-2019-02259
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: 9600LDS26A
• Device Lot Number: 61807309
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 08/01/2019; 07/23/2020
• Supplement Dates FDA Received: 08/02/2019; 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR