MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS EXPANDABLE SHEATH INTRODUCER SET, 16F; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 916ESA

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528); Material Rupture (1546); Failure to Align (2522); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.Udi # (b)(4).

Event Description

As per pre-decontamination observation, the liner was circumferentially delaminated and sheath shaft is torn along the hdpe.During a transfemoral procedure with a 29mm commander delivery system, valve alignment in the straight section of the aorta was attempted but the valve could not be aligned in the aorta.Troubleshooting was performed by adjusting the fine adjust wheel, moving up and adjusting approximately 4mm from the distal tip of the marker.The delivery system was not pulled past the warning marker.There was tension in the system.It was discussed that the balloon may not be intact.An attempt was made to withdrawal the system, but difficulty was encountered.A decision was made to deploy the valve in the thoracic aorta.The balloon was unlocked and inflated with nominal volume.The atrion syringe filled with blood and it appeared that the balloon had ruptured.A decision was made to continue to withdrawal the system as unit.Difficulty was noted withdrawing the delivery system/valve through the 16fr sheath as the system was getting caught on the sheath tip.The sheath and delivery system could not be removed through the groin and the aorta was opened to remove the system.The patient is stable.The valve was not deployed.The patient¿s aorta was moderate to severely calcified and tortuous at the bend of the groin.The patient had "large" iliac arteries.There was no crossing difficulty.

Manufacturer Narrative

The esheath was returned to edwards for evaluation.Visual inspection revealed the following: a kink approximately 4¿ from the sheath housing assembly at the end of the strain relief, sheath was expanded as designed, sheath distal tip was opened as designed, liner was circumferentially delaminated 2 ¿ in length, severe scratches on the sheath shaft, kinks on the sheath, minor punctures on the sheath distal tip, minor liner tear, sheath distal tip was split, c-marker was attached to the liner material, and minor soft tip damage.Imaging was provided and revealed the access vasculature shows signs of severe tortuosity and calcification.The crimp balloon was torn, and the inflation balloon was bunched near the nose tip, so the inflation balloon profile was altered or enlarged.Functional or dimensional testing was not performed due to the condition of the returned device.During the manufacturing process, inspections are in place to detect defects related to the complaint events.The sheath shaft is 100% inspected per procedure for defects.During manufacturing of the sheath components, the sheath shaft tip is dimensionally inspected.During the final inspection, the esheath undergo 100% inspection by both manufacturing and quality per procedure.Additionally, the esheath is tested and inspected on sample devices from each lot during product verification (pv) testing.The samples were inspected for sheath kink resistance, seam separation, expansion force, and seam expansion testing.No failures occurred during product verification testing and the lot was released.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.A device history records (dhr) review and lot history 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.A review of the complaint history from july 2019 to june 2020 revealed other similar returned complaints for the trend categories above were confirmed.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.Available information suggests that procedural/patient factors may have contributed to the events.A review of complaint history revealed that the occurrence rate did not exceed the june 2020 control limit for all the trend categories.The esheath ifu, prepping manual, and device training manual were reviewed for instructions involving device preparation and procedures relating to the complaint event.The training manual provides guidance on thv retrieval through sheath.Thv can be retrieved through the sheath only before thv deployment (still crimped), ensure the thv is centered on the flex tip, ensure the 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, and do not re-use the sheath, thv or delivery system once thv is retrieve.In addition, note that the 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, and note retrievability is based on preclinical testing.In addition, if the delivery system balloon ruptures or leaks during deployment without thv embolization, do not use excessive force, take care when crossing the thv, tracking back over the arch and removing the delivery system (through the tip of the sheath), maintain guidewire position, check for pv leaks under echo and if post-dilation needed, use a new delivery system.Based on the review of the ifu/training manuals, no deficiencies were identified.The complaint was confirmed based on observations from the returned device and provided imagery.However, investigation of the device, complaint history, lot history, and dhr revealed no indication that a manufacturing non-conformance contributed to the event.A review of ifu/training materials revealed no deficiencies.Per imagery review, the patient had severely tortuosity anatomy, which could be potentially contributed to the kinked of sheath shaft.Furthermore, the delivery system experienced withdrawal difficulty through the sheath.So, if excessive force was applied, the sheath shaft could be kinked.Per complaint report, one (1) valve strut was bent outward at the outflow.This indicates that excessive force was applied during the crimped valve retrieval, which could lead to sheath shaft punctured.Additional imagery review, patient had severely tortuosity anatomy, and the valve could be withdrawn sub-optimal angles through the sheath, which could also lead to punctures on sheath shaft.As reported, ¿difficulty was noted withdrawing the delivery system/valve through the 16fr sheath as the system was getting caught on the sheath tip.¿ as it was reported, so the delivery system balloon was torn, and inflation balloon profile was altered or enlarged, which could have led to additional forces exerted to the withdrawal balloon leading to liner delamination/split.So, if excessive force was applied during the retrieval/withdrawal of delivery system (with crimped valve and altered profile inflation balloon), it could lead to sheath distal tip liner delamination and split.Per training manual, ¿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.¿ in this case, available information suggests that patient factors (anatomy tortuosity) and/or procedural factors (excessive device manipulation) may have contributed to complaint event.However, a conclusive root cause could not be determined at this time.A review of ifu and training materials revealed no deficiencies, and review of the complaint history revealed that the complaint occurrence rate did not exceed the june 2020 control limit for the applicable trend category.No corrective or preventative action, nor product risk assessment is required.

Manufacturer Narrative

This supplemental mdr is being submitted for reference of mfg.Report numbers for this complaint.This is 2 of 3 reports being submitted for this complaint; reference mfg.Report numbers: 2015691-2020-12320 and 2015691-2020-12322.

Manufacturer Narrative

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

• Brand Name: EDWARDS EXPANDABLE SHEATH INTRODUCER SET, 16F
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10203714
• MDR Text Key: 197333433
• Report Number: 2015691-2020-12321
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• 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,Followup
• Report Date: 06/02/2020

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: 03/16/2022
• Device Model Number: 916ESA
• Device Lot Number: 63052521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 06/26/2020; 08/18/2020; 07/23/2020
• Supplement Dates FDA Received: 06/26/2020; 08/28/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR