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

Model Number 9610TF26

Device Problem Air Leak (1008)

Patient Problem Failure of Implant (1924)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.Reference mfg.Report #2015691-2018-02401.

Event Description

As reported through our (b)(6) affiliate, during valve deployment the balloon of the commander delivery system did not inflate.Difficulty was encountered during withdrawal of the delivery system.A cut down was performed to remove the devices through the iliac.All the devices were removed and the valve was not implanted.The patient was stable.The patient¿s vessel minimum luminal diameter measured 8.0 mm to 9.0 mm.

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.During balloon manufacturing, the commander delivery system including both inflation and crimp balloons undergoes inspections for the following: working length, balloon diameter, proximal and distal leg ids, proximal leg od, double wall thickness measurements, distal length, proximal length, distal id, proximal id, and single wall thickness.In addition, the balloons are 100% visually inspected for general appearance/gross defects.The balloons are 100% visually inspected under 8x magnification for foreign matter, impurity or contamination, fish eyes, and gel spots.The crimp balloon to inflation balloon laser bond and balloon catheter laser bond are 100% inspected.During the pleat, fold and forming process, the delivery system balloon is inspected for balloon size and contamination.After the process the balloon is inspected for fold lines and distorted/pinched folds.During final inspection the entire device is inspected for damage or missing components and the balloons for distorted/pinched folds.The commander delivery system is 100% leak tested.During product verification (pv) testing using sample devices are tested.The samples are inspected for physical defects or damage.In addition, the inflation/crimp balloon and nose tip/inflation balloon bonds are visually inspected for tears or separations.Functional testing for inflation balloon/nose tip, inflation balloon /crimp balloon, and crimp balloon/balloon shaft are all inspected for tensile strength.The samples passed this test as per tensile strength parameters.No failures occurred during product verification testing and the lot was released.These inspections during the manufacturing process support that it is unlikely a manufacturing nonconformance contributed to the complaint events.A device history record (dhr) review was performed and revealed no manufacturing related issues that could have contributed to the reported events.A review of lot history revealed one other similar complaint and is pending engineering evaluation.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.Without photographs, imagery, or the devices themselves, a definite source for the balloon leakage cannot be determined.However, since the device was able to be successfully de-aired, it is likely that the leakage source was not present on the device out-of-box and was created during the procedure.Patient/procedural factors that can result in balloon leakage include the following: excessive manipulation of the delivery system during the procedure (e.G.During delivery system insertion/advancement or valve alignment) results in kinking or damage to the balloon shaft or balloon catheter bonds (i.E.Nose tip/inflation balloon, crimp balloon/balloon shaft).Kinking of the delivery system during insertion/advancement or improper insertion of the stylet or guidewire results in damage to the guidewire lumen.Calcification in the patient anatomy damages the inflation balloon and/or crimp balloon.Area of the crimp balloon proximal to the inflation balloon to crimp balloon bond damaged during valve alignment.Performing alignment in a non-straight area could result in increased forces being applied to the bond area causing damage adjacent to the bond area.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, which could lead to a tear in the inflation and crimp balloon bond.This was recreated in a previously performed engineering study, which demonstrated that residual volume in the inflation balloon during valve alignment can create high enough valve alignment forces to potentially cause a material failure in the area in question.Based on provided case information, it is unclear where or how the delivery systems and/or valves were caught during retrieval.Per training manual, the operator is instructed to ensure the thv is centered on the flex tip, then to retract the thv/delivery system into the sheath, ensuring the thv is completely inside the sheath before withdrawing the delivery system and sheath as a single unit completely from the arteriotomy.However, a review of complaint history suggests that the following procedural factors could have contributed to the reported withdrawal difficulties: a torn crimp balloon results in exposed inflation balloon wings.If the valve was not centered/flush against the flex tip, the balloon wings could then get caught on the sheath tip, flaring them and preventing retrieval of the delivery system fully into the sheath.Difficulty retrieving the delivery system may have resulted in higher forces being applied to withdraw the system.Additionally, if the valve is not centered/flush against the flex tip prior to attempted retrieval, the valve may get caught on the vasculature or sheath tip, resulting in withdrawal difficulty.As such, it is likely that patient/procedural factors contributed to the reported events.However, based on available information, a definite root cause cannot be determined at this time.The complaints were unable to be confirmed.Due to the unavailability of the devices, it cannot be confirmed if a manufacturing nonconformance contributed to the reported events.However, in this case, available information patient/procedural factors likely contributed to the reported events.No labeling or ifu/training inadequacies were identified.A review of complaint history revealed that the complaint rates did not exceed the june 2018 control limits for their respective trend categories.As such, no corrective or preventative actions are required.

Manufacturer Narrative

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

• Brand Name: EDWARDS 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: 7629799
• MDR Text Key: 112567962
• Report Number: 2015691-2018-02404
• 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
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2020
• Device Model Number: 9610TF26
• Device Lot Number: 61229702
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 87 YR