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

Model Number 9610TF26U

Device Problems Burst Container or Vessel (1074); Calcified (1077); Difficult to Remove (1528); Separation Failure (2547)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our (b)(6) affiliate, during implant of a 26 mm sapien 3 ultra valve in the aortic position, the commander delivery system balloon burst during partial inflation with 2 cc less of volume.There was no injury to the patient.During removal of the system difficulty was encountered.2 snares were utilized to remove the system; however, no cut down was needed.There were no remaining pieces of the device left in the patient.The valve outcome was good, and the patient was stable.As reported, there was no balloon valvuloplasty (bav) performed.The patient¿s native leaflets were moderately calcified, and the aortic root was severely calcified.The patient¿s aorta was porcelain.

Manufacturer Narrative

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

Manufacturer Narrative

This report is 1 of 2 being submitted for this complaint.Reference mfg.Report no.2015691-2020-11296.

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.A photograph was provided and showed the balloon burst and the distal tip of the delivery system separated from the proximal taper of the inflation balloon.In addition, patient imaging was provided and revealed that the sinotubular junction and sinus of valsalva were calcified and the native annulus was calcified.During manufacturing, the entire delivery system (including the crimp balloon, inflation balloon, and nose tip) is visually inspected and tested several times.Per procedure, the balloons are 100% visually inspected for defects.During the crimp balloon molding process, the balloons are 100% dimensionally and visually inspected per procedure.The guidewire shaft to nose bond is visually inspected.The laser weld joint is 100% visually inspected.Prior to balloon pleat, fold and forming process the balloons are 100% visually inspected.The commander delivery system is 100% leak tested and post-leak test the device is visually inspected per procedure.During final inspection, the entire device is 100% inspected distal to proximal by both manufacturing and quality.In addition, the lot undergoes product verification (pv) testing as a requirement for lot release.The device is visually inspected for defects, the balloons are inspected and the nose/tip guidewire shaft bond is visually tested.During pv testing, the balloons are tensile tested, burst pressure test and retrieval forced tested.All samples passed these tests.These inspections during the manufacturing process and testing performed during the product verification make it unlikely that a defect in manufacturing contributed to the reported events.A device history record (dhr) review is performed and did not reveal any manufacturing non-conformance that would have contributed to the reported event.A review of the lot number did not reveal any additional complaints for the reported events.A review of complaint history from (b)(6) 2019 to (b)(6) 2020 for the edwards commander delivery system (all models and sizes) revealed additional returned complaints for the complaint codes of this evaluation.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.Available information suggests that patient/procedural factors contributed to the events.A review of complaint history revealed that the occurrence rate did not exceed the march 2020 control limit for all the trend categories.The ifu for commander delivery system, device prepping manual and procedural training manual were reviewed for guidance and instruction on device preparation and usage involving the commander delivery system and esheath usage.The procedural training manual provides guidance on delivery system balloon bursts.If a balloon burst is suspected, do not attempt to pull back the delivery system into the sheath until you are prepared to conduct the following steps: attempt to visualize location of tear either in tee or via angio through the pigtail or catheter/delivery system, when removing, ensure the catheter/delivery system and wire are coaxial with the sheath tip.Watch under fluoro with every movement.Be patient and pull gently especially near tear and balloon shoulder transitions, do not force if resistance is met near or at the sheath tip.Force could result in additional tearing of the balloon material and the balloon material or tip coming off, if successful in pulling the entire balloon and delivery system tip into the tip of the sheath, withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position, and do not attempt to pull the delivery system through the remaining length of the sheath.In addition, if unable to pull the entire balloon into the sheath, do not attempt to remove the exposed balloon through the entire peripheral vasculature, as there is risk of major complications.Conversion to surgery is recommended to remove the system and a surgeon should be in a position to be able to evaluate the situation.Based on a medical assessment of the size, tortuosity, and extent of calcification of the peripheral vessels, evaluate the risks and tradeoffs of carefully withdrawing the system into a more peripheral anatomy in order to allow a more localized surgical procedure.Consider use of an occlusion balloon to mitigate bleeding risks, especially if there is resistance encountered during withdrawal.If resistance is unacceptably high, convert to surgery rather than using excessive force to pull the sheath/delivery system to a different position and ensure the valve is well opposed.If it is not, you must post dilate immediately with another balloon or delivery system and sheath.Take care when crossing the deployed valve to prevent potential embolization.No ifu or training deficiencies were identified.The complaints were confirmed based on returned imagery.As a result, presence of manufacturing non-conformances was unable to be determined.A review of dhr, complaint history, lot history, and manufacturing mitigations provided no indication that a manufacturing non-conformance contributed to the reported events.A review of ifu/training materials revealed no deficiencies.As per report, the patient had moderate native leaflet calcification and severe aortic root calcification.The provided patient imagery also shows calcification of sinotubular junction, sinus of valsalva, and leaflets.Based on available evidence, it was found that calcification can present a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressures, calcified nodules in the patient anatomy can compromise the structure of the balloon wall even at low inflation pressures.This can occur due to mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.Once the inflation balloon burst, the profile of the balloon would have been altered.This would have created difficulty in withdrawing the delivery system, as the burst balloon likely caught on the tip of the esheath.As per the case notes, the patient¿s access vessel had a moderate degree of tortuosity.Tortuosity in the access vessel can cause non-coaxial retrieval angles.This would have further exacerbated delivery system withdrawal difficulties through the sheath.It is likely that additional force was applied to overcome the withdrawal difficulties, resulting in the observed separation of the distal tip.In this case, it is likely that patient (calcification/tortuosity) and/or procedural factors (withdrawal of burst balloon/excessive device manipulation) contributed to the reported events.However, based on available information, a conclusive root cause cannot be determined at this time.No ifu/training manual deficiencies were identified, and review of complaint history revealed that the occurrence rates for the applicable trend category did not exceed march 2020 control limit.Therefore, neither pra escalation nor corrective actions are required at this time.

• 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: 9918857
• MDR Text Key: 188668790
• Report Number: 2015691-2020-11295
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Model Number: 9610TF26U
• Device Lot Number: 62778302
• 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 Age: 73 YR
• Patient Weight: 55