MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600LDS23A

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Material Separation (1562); Failure to Align (2522); Material Deformation (2976); Mechanical Jam (2983)

Patient Problems Perforation of Vessels (2135); Blood Loss (2597)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During deployment of a 23mm sapien 3 valve in the pulmonic position inside a non-edwards bioprosthesis valve, the delivery system did not align the valve correctly.During removal of the sheath and delivery system/valve, ¿great¿ difficulty was encountered resulting in vascular repair (venous).Per report, during advancement of a 14fr esheath, the guidewire kinked as per imaging.An attempt was made to align the valve in ivc ra junction.Issues occurred with valve alignment with the 23mm s3 due to the patient wearing a lead apron (patient was (b)(6) pregnant).The valve was noted to be ¿canted¿ post alignment.A decision was made to remove the kinked guidewire, sheath and delivery system/valve and insert a new delivery system/valve.After the valve was pulled into the sheath, the delivery system/valve was pulled as a unit and it was noted that the sheath separated from the valve, making extraction of the valve difficult.The valve was caught underneath the skin but would not come out.Significant resistance was encountered.A cut-down was performed, resulting in successful retrieval of the valve, maintaining wire position.However, the 14-french delivery sheath was replaced and there was significant bleeding around the sheath.The esheath was exchanged for a larger 20 fr cook sheath which also had bleeding around the sheath.It was decided to continue the tvr and a new 23mm s3 was advanced while ¿manual pressure¿ was held on the groin.Blood loss was replaced by (anesthesia) in order to keep patient ¿euvolemic.¿ the valve was deployed well (no gradient) and a vascular surgeon repaired the right femora vein (4 units of blood given).The patient was stable and transferred for post management care.The devices were discarded.Per report, a perceived root cause was the kinked wire (manual curve) and the valve being mounted in the straight part of the body (ivc ra junction).

Manufacturer Narrative

The commander delivery system 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.There was no photo or imagery provided.Device history record (dhr) review and the lot history review could not be completed as lot number was not provided.Assembled devices undergo 100% final inspection by both manufacturing and quality.Functional inspection of the device is performed.In addition, each lot is required to undergo product verification testing on a sampling basis.All samples selected from each lot must pass the following tests: visual inspection to ensure device is free from physical defects, fine adjustment verification test, retrieval force and engagement force test.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the complaint event.A review of complaint history from may 2018 to april 2019 for the edwards commander delivery system (all models and sizes) revealed other similar complaints.However, no manufacturing non-conformance's were identified during the investigations of the similar complaints.Available information suggested that patient/procedural factors may have contributed to the events.A review of complaint history revealed that the occurrence rate did not exceed the april 2019 control limit for all the trend categories.The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator).The sapien 3 valve is currently not indicated for use in a pulmonic valve-in-valve application.Available ifu/training materials are reviewed for instructions that may be relevant to the complaint event; however, instructions may not describe the entire procedure as described per the complaint report.The commander delivery system ifu, prepping training manual, and procedural training manual were reviewed for instructions or guidance for proper use of the commander delivery system.The procedural training manual provides instruction for valve alignment.Factors that can assist with valve alignment are as follows: unlock, pull the balloon catheter straight back at the y-connector until part of the warning marker is visible and lock, do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure, rotate the balloon lock away from you to lock and towards you to unlock.Lock/unlock symbols are found on the balloon lock check delivery system before valve alignment.If kinked, do not use, slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap.If additional fine adjustment is needed, unlock and rotate the fine adjustment wheel away from you until part of the warning marker is visible and relock.Compression may be observed in the distal portion of the flex catheter during valve alignment.Diving may be observed between the thv and flex catheter tip during valve alignment.The procedural training manual provides instruction for thv retrieval through sheath.Instruction includes: thv can be retrieved through sheath only before thv deployment (still crimped), ensure the thv is centered on the flex tip, ensure delivery system is locked, verify the flex catheter is completely unflexed, retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip, ensure the edwards logo on the sheath handle is facing upward.Withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.Do not re-use the sheath, thv or delivery system once thv is retrieved.Note: crimped thv aligned on balloon is larger than crimped thv off balloon.Take care if deciding to retrieve.Note: do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip.Stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure.Per the complaint, the valve was ¿aligned canted on the balloon¿.This suggests that valve diving was present during valve alignment.Potential factors that could cause valve diving include performing valve alignment in a non-straight section of the anatomy and improper crimping of the valve.It should be noted that the complaint states that valve alignment was performed in a straight section of the anatomy.A root cause was unable to be definitively determined.Since the sheath came out while the delivery system was still inserted, the delivery system and valve were exposed in the vasculature.In conjunction with the described valve canting, this may have resulted in the observed vascular injury.However, not enough information was provided to determine a root cause.No potential manufacturing non-conformance's were identified.A root cause was unable to be determined conclusively.No labeling or ifu/training inadequacies were identified.The occurrence rate for the relevant trend category did not exceed the monthly trigger for action.No corrective or preventative action is required.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 23MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8565128
• MDR Text Key: 143662036
• Report Number: 2015691-2019-01532
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2019

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
• Device Operator: Health Professional
• Device Model Number: 9600LDS23A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 06/03/2019; 07/23/2020
• Supplement Dates FDA Received: 06/06/2019; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR