MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF26

Device Problem Air Leak (1008)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported through our (b)(4) affiliate, during deployment of a 26mm sapien 3 valve in the aortic position, the commander delivery system balloon partially inflated.The valve was withdrawn into the aorta and the delivery system was removed from the patient with a cut down in the groin.A new system was used and the procedure successfully completed.Patient was stable and was discharged.As per report, the balloon could have been damaged when it was introduced in the heavily calcified femoral artery.

Manufacturer Narrative

The commander delivery system was returned to edwards for evaluation.Visual inspection revealed the following: a tear on the crimp balloon adjacent to the inflation balloon/crimp balloon (i/c) bond, balloon legs bent back, the valve is aligned, and gouges on flex tip.Functional testing was not performed due to the returned condition of the device (balloon torn).Dimensional testing was performed on the double wall thickness on the crimp balloon proximal to the observed separation and was found to be in within specification (the area distal to the separation could not be measured as that area consists of the bond area and inflation balloon).During balloon manufacturing, the entire delivery system (including the crimp balloon, inflation balloon and nose tip) are 100% inspected.Samples are pulled for inspection for setting up, adjusting, operating and cleaning the standard extruder (crimp balloon tubing).Per routing instructions, samples are inspected per boxed inspection dimensions, length, and general notes per drawing.The crimp balloon tubing is inspected by manufacturing for designated drawing general notes, and inside diameter (id) of tubing lumens.A 100% wall thickness inspection is performed.The inflation balloons are 100% inspected for the following dimensions: working length, balloon diameter, proximal and distal leg ids, proximal leg od, and double wall thickness.Balloons are sampled for burst testing and additional visual inspection.The crimp balloon features are 100% dimensionally inspected for the following: distal length, proximal length, distal id, proximal id, single/double wall thickness, center balloon wall, measure the balloon double wall thickness at the center of the flattened balloon, and compare measurement to the drawing specifications.The balloons are 100% visually inspected for general appearance/gross defects, foreign matter, impurity or contamination, fish eyes, and gel spots.The i/c laser bond weld is 100% inspected for bubbles to ensure that there is a smooth bond joint with no gaps between components.In addition, the balloon is 100% visually inspected under 2.85x minimum magnification for balloon size, contamination, fold lines, and distorted/pinched folds.During final manufacturing the commander delivery system is 100% inspection by manufacturing and quality for the following: damage or missing components, distorted/pinched folds.During manufacturing, the commander delivery system was 100% leak tested.During product verification (pv) testing is performed on lot samples for balloon pressure and met statistical requirements.Additionally, under pv tensile testing, the locknut/collet engagement force was measured and met statistical requirements.The lot met requirements prior to release for distribution.The above inspections during the manufacturing process and testing performed during pv support that it is unlikely a manufacturing non-conformance contributed to the reported.A device history records (dhr) review did not reveal any issues that could have contributed to the reported events.A review of lot history for work order revealed no other similar complaints.The tubing lots and resin for the crimp balloon underwent further review, and in this case, were no issues were identified.A review of complaint data for may 2018 revealed that the complaint rate did not exceed the control limit for the applicable complaint trend category.Review of the ifu and training manual was performed and no deficiencies were identified.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, additional assessment of the failure mode is not required at this time.The complaint balloon torn was confirmed based on visual inspection of the returned device.A review of complaint history, lot history, manufacturing mitigations, and the dhr revealed no indication that a manufacturing non-conformance contributed to the event.In addition, dimensional inspection of the device met specification.A review of ifu/training materials revealed no deficiencies.Since the device was able to be prepped (including de-airing) without any reported issues, it is likely that the damage to the balloon occurred during use and was not present upon leaving the manufacturing facility.A review of complaint history revealed that potential root causes for separation of the crimp balloon material proximal to i/c bond have been identified and previously documented in a product risk assessment (pra), as per management discretion.Although imagery of the patient anatomy was not provided, if the physician performed the valve alignment process in tortuous anatomy, it could result in increased forces being applied to the bond area.This may occur as performing valve alignment at a bend or angle can cause the thv to unseat (non-coaxial placement of valve in relation to the flex tip) from the flex tip during alignment and ¿dive¿ into the lumen of the flex tip, where part of the crimped valve slides into the flex tip.If the thv is unseated during alignment, it can result in higher than usual valve alignment forces, and can potentially weaken the bond between the inflation balloon and crimp balloon if excessive force is used to try and achieve final alignment position.Visual inspection revealed gouges on the flex tip, which indicate the presence of valve diving.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high enough valve alignment forces to potentially cause a material failure in the area in question.In addition, residual volume left in the balloon may also contribute to increased forces during valve alignment or delivery system retrieval, which could lead to a weakening of the inflation and crimp balloon bond as recreated in a previously performed engineering study.Calcification may have also contributed to the balloon tear.Per the complaint description, ¿the balloon could have been damaged when it was introduced in the heavily calcified femoral artery.¿ visual observation of the sheath shaft also revealed heavy scratches, supporting the presence of calcification.Calcification can catch onto the balloon and cause the material to weaken.The tear may have then expanded during valve alignment or balloon inflation.The complaint was confirmed.In this case, available information suggests patient and/or procedural factors (valve alignment in a non-straight section/calcification) may have contributed to the complaint event.Although no product non-conformance was confirmed in the returned complaint sample and the occurrence rate did not exceed the control limit, further investigation was performed on the crimp balloon tubing and resin lots.In addition, a capa is being updated to address the emerging trend in i/c bond complaints.

Manufacturer Narrative

This is one of two mdrs, reference mfg.Report #2015691-2018-02784 the delivery system was returned to edwards lifesciences for evaluation.Preliminary engineering inspection revealed a crimp balloon tear, the balloon wings are bent back.Investigation of this event is ongoing.

Manufacturer Narrative

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

• Brand Name: EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7607456
• MDR Text Key: 111298519
• Report Number: 2015691-2018-02313
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2019
• Device Model Number: 9610TF26
• Device Lot Number: 60870300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention