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

Model Number 914ESA

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Mechanical Jam (2983); Material Split, Cut or Torn (4008)

Patient Problems Death (1802); Extravasation (1842); Low Blood Pressure/ Hypotension (1914)

Event Date 06/04/2020

Event Type  Death  

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.Udi (b)(4) investigation is underway.

Event Description

As reported by an edwards lifesciences field clinical specialist, a 14fr esheath was inserted in the patient¿s right femoral artery with a remark that the vessel felt ¿crunchy¿.  there was greater than normal difficulty advancing the commander delivery system and valve through the esheath and the system became stuck in the mid reia.Propofol was injected into the side arm of the esheath as a lubricant.The esheath was retracted while attempts were made to simultaneously advance the commander; however, the delivery system remained stuck within the sheath.  a decision was made to remove the esheath/commander/sapien3 ultra as a unit but was unsuccessful.During this attempt the commander delivery system came apart with the distal portion of the commander and the valve remaining in the esheath.Attempts to pull the esheath out were unsuccessful.The patient became hypotensive and the abdominal aortic angiogram revealed extravasation in the reia around the esheath.A coda balloon was inserted from the contra lateral side and the patient was given blood and pharmacologic treatments.The patient blood pressure was stabilized with coda inflated.A retroperitoneal cut down was performed, the iliac artery isolated and  esheath was removed.It was observed that the esheath had become ¿split open¿ with the sapien 3 ultra valve coming through the seam.  during the surgical iliac repair, ¿large chunks of calcium¿ were excised from the damage vessel.A conduit was sewn on to the common iliac.A 20 fr gore dryseal sheath inserted into the conduit.The coda balloon was partially deflated to allow passage of the dryseal sheath into the aorta.A new 26mm s3 ultra valve and commander were prepped and advanced through the dryseal sheath through the conduit.The patient became severely hypotensive at this time, possibly because the coda was partially deflated.The valve was deployed successfully and the remainder of the delivery system was retracted.Resuscitative efforts were continued, including chest compressions and defibrillation.The patient never regained an adequate bp and expired on the table.The hospital retained the damaged esheath and commander.

Manufacturer Narrative

The devices were not returned for evaluation.Review of procedural videos/imagery/photographs were performed, and the following was observed the 2-year-old 3mensio imagery shows calcification in patient¿s vessels.There appears to be a ¿focal spot in right iliac of heavy calcification¿, the patient¿s access vessels with tortuosity present.A photo of device after use shows sheath liner tear and crimped valve exposed through torn sheath liner.A device history review (dhr) was performed and did not reveal any manufacturing non-conformance that would have contributed to this complaint event.  review of lot history revealed no other similar complaints related to the reported events.A review of the complaint history from (b)(6)2019 to (b)(6)2020 revealed other returned complaints for the reported events (all esheath models and sizes).The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.A review of complaint history revealed that the monthly occurrence rate did not exceed the (b)(6)2020 control limit for the trend categories.Per ifu and training:  precautions:  caution should be used in vessels that have diameters less than 5.5 mm or 6 mm as it may preclude safe placement of the 14f and 16f edwards esheath introducer set respectively.  use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set.  do not use the edwards esheath introducer set if the packaging sterile barriers and any components have been opened or damaged.  when inserting, manipulating or withdrawing a device through the esheath, always maintain orientation of the sheath position.  delivery system insertion through sheath:  insert the loader until it stops.For valve sizes 20, 23 and 26 mm, loader does not peel away.Keep loader completely inserted in sheath until just before delivery system removal at end of procedure to maximize system working length.  insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion.  in expectation of high friction, use short movements and push delivery system closer to sheath hub.  note: in expectation of high friction, use short movements.  push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification.Following proper valve crimping technique and ensure valve is delivered as straight as possible.  be careful to not bend the proximal end of the sheath when inserting the delivery system through the sheath.  if push force is too high or valve is initially stuck, zoom in and rotate the c-arm to ensure valve and sheath are not damaged.  if damaged, retract valve in sheath slightly.Remove valve and sheath together as single unit and replace.  if push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system.  if push force is too high or valve is still stuck, remove valve and sheath together as a single unit and replace.  do not over-manipulate the sheath at any time.  caution: the thv should not be advanced through the sheath if the sheath tip is not past the aortic bifurcation.  instructions for use (ifu), prepping manual, and device training manual were reviewed for instructions involving device preparation and procedures relating to the complaint event.Based on the review of the ifu/training manuals, no deficiencies were identified.During manufacturing, the esheath is both visually inspected and tested several times throughout the process.These inspections during the manufacturing process support that it is unlikely that a defect in manufacturing contributed to the complaint event.The reported event for the resistance with the delivery system was confirmed based on the returned imagery.However, no manufacturing nonconformance was identified during the evaluation.A review of the dhr, lot history, complaint history and manufacturing mitigations did not provide any indication that a manufacturing nonconformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Per the provided 3 mensio report, there appears to be a focal spot of heavy calcification in the access vessel.As reported in the cer, ¿during the surgical iliac repair, large chunks of calcium were excised from the damage vessel.¿ calcification present in the vessel can prevent the sheath from fully expanding to allow for the advancement of ds/crimped valve through the sheath.It was also reported that the mild-moderate pvd noted on the 2-year-old 3mensio report may have advanced into a moderate-severe degree of disease which is likely a contributing factor to the inability to advance the ds/valve through sheath.As a result, available information suggests that patient (moderate-severe access vessel calcification) factors contributed to the reported event.The reported events of liner tear and withdrawal difficulties were confirmed based on the returned imagery.However, no manufacturing nonconformance was identified during the evaluation.A review of the dhr, lot history, complaint history and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.An existing technical summary has been documented for root cause analysis on sheath shaft liner tears.In this technical summary, a review of liner tear complaint investigations on returned devices over a two year period found that patient factor (e.G.Access vessel calcification) is likely the contributing factors for sheath shaft liner tears.Calcification present in the access vessel can damage the exposed portion of the sheath liner, which could lead to immediate cutting/tearing of the sheath liner or the weakening of it.A weakened liner can tear during advancement or retrieval of the delivery system.Additionally, per the cer, ¿it was observed that the esheath had become split open with the sapien 3 ultra valve protruding through the seam.This esheath damage most likely occurred during the aggressive manipulation of the commander while attempting to remove it from the vessel¿.It is possible that the excessive manipulation of the delivery system in the attempt to remove the stuck valve from sheath lead to damaged valve frame/struts to interact with the sheath and further propagate the tear in the sheath liner.As seen in the provided imagery, the valve struts appear to be damaged and bent outwards which is likely due to valve struts catching on calcification.If the valve is caught on calcium nodules and stuck inside the sheath, it can create a difficulty removing the sheath/valve system from the vessel which could have resulted in the reported sheath withdrawal difficulty.However, a definitive root cause could not be determined at this time.Available information suggests that patient factors (severe-moderate access vessel calcification) and procedural factors (excessive device manipulation/sheath removal with valve caught on calcification) likely contributed to the liner tears.The reported event is an anticipated risk of the transcatheter valve procedure.A review of the risk management documentation was performed.  no product defect/non-conformance or ifu/training inadequacies was identified during the evaluation.Initial investigation did not show any evidence that an edwards defect contributed to the reported event, therefore no corrective actions are required.Since no product non-conformances were identified, a product risk assessment (pra) escalation is not required.However, pra has been previously initiated to assess patient risks associated with sheath shaft resistance with the commander delivery system and sapien 3 ultra thv configuration.The reported events of resistance with delivery system was confirmed based on the returned imagery.Due to no product returned, visual inspection, dimensional/ functional testing was unable to be performed.Therefore, no manufacturing nonconformance were identified during evaluation.Available information suggests that patient factors (moderate-severe access vessel calcification) contributed to the reported event.No ifu/labeling/training manual inadequacies were identified; therefore, no corrective or preventative action nor pra is required at this time.However, per management discretion, pra has been previously initiated to assess patient risks associated with sheath shaft resistance with the commander delivery system and sapien 3 ultra thv configuration.The reported event for the liner tear was confirmed based on the returned imagery.No manufacturing nonconformance was identified and available information suggests that patient (moderate-severe vessel calcification) and procedural (excessive device manipulation) factors may have contributed to the complaint event.Since no ifu/labeling deficiencies were identified and the occurrence rate did not exceed the (b)(6) 2020 control limit for the trend category ¿damaged¿, no corrective or preventative action, nor pra was required.The complaint for withdrawal difficulty was confirmed based on the returned imagery.Due to no product returned, visual inspection, dimensional/ functional testing was unable to be performed.Therefore, no manufacturing nonconformance were identified during evaluation.Available information suggests that procedural factors (sheath removal with valve caught on calcification) contributed to the reported event.However, a definitive root cause was unable to be determined.No ifu/labeling/training manual inadequacies were identified, and the occurrence rate did not exceed the (b)(6)2020 control limit for the trend category ¿withdrawal difficulty¿, no corrective or preventative action, nor pra was required.

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.  please reference related manufacturer report no:2015691-2020-12256.Manufacturer report no:2015691-2020-12257.Manufacturer report no:2015691-2020-12258.

Manufacturer Narrative

Updating fda report followup task owner.

• Brand Name: EDWARDS EXPANDABLE INTRODUCER SHEATH SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10190352
• MDR Text Key: 196322434
• Report Number: 2015691-2020-12256
• 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,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Model Number: 914ESA
• Device Catalogue Number: N/A
• Device Lot Number: 62888638
• 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): Death
• Patient Age: 91 YR