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

Model Number 914ESA

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2020-12315.Investigation is ongoing.

Event Description

As reported, during a transfemoral transcatheter aortic valve replacement (tavr) procedure with a 23mm sapien 3 ultra valve in the aortic position, the valve frame was caught on calcium transecting the iliac.Per report, a 14fr esheath was placed in the right femoral artery with no problem.Resistance was felt while advancing the valve; the valve was stuck in the right common iliac artery due to a tine from the valve frame was caught on the sheath and transected the iliac.The devices were removed as a unit.A stent was placed to repair the artery.The patient is well post procedure.

Manufacturer Narrative

A 14f sheath with the tip unexpanded was returned with the delivery system (crimped thv over inflation balloon) was also returned for evaluation.  a review of imagery provided showed the following:  presence of calcification and tortuosity in patient¿s access vessel; the access vessel had a minimum luminal diameter (mld) of 5.4mm, which is slightly lower than the recommended 5.5mm for 14f esheath.  visual inspection was performed and the following was observed: distal portion of sheath 1.5¿ unexpanded; liner torn 5¿ in length starting at strain relief; two liner strands: liner strand 8cm in length; liner strand entire length of liner tear; two punctures:  puncture on hdpe shaft 5¿ distal from end of strain relief;  puncture on hdpe shaft 3.5¿ distal from end of strain relief; distal section at strain relief is torn.  visual inspection of the returned commander delivery system and valve was also performed, and the following was observed: the crimped valve was noted to be over the inflation balloon; retrieval of the delivery system through the sheath may have caused the thv to shift from the crimp balloon onto the inflation balloon.Two valve struts were bent outwardly on the inflow side.  due to the nature of the complaint (sheath liner tear), no functional testing was able to be performed.The liner thickness was measured along the length of the tear.The liner thickness was found to be within specification at all measured locations.These inspections during the manufacturing process support that it is unlikely that a defect in manufacturing contributed to the complaint event.During manufacturing, the esheath is both visually inspected and tested several times throughout the process.The sheath shaft components were 100% visually inspected for any defects.During the manufacturing process the esheath final assemblies were 100% visually inspected by both manufacturing and quality.Furthermore, after sterilization, sheath expansion testing was performed during product verification (pv) on finished devices from the work order under a sampling basis.A review of complaint history from july 2019 ¿ june 2020 revealed similar returned complaints for the esheath (all models and sizes) for sheath shaft resistance with delivery system, liner torn, liner strand, and damaged.  the complaints were confirmed, however, no manufacturing nonconformities were identified in the evaluations.  available information suggests that patient and or procedural factors may have contributed to the events.The complaints for sheath shaft resistance with delivery system, liner torn, liner strand, and damaged were confirmed based on the condition of device return.However, no manufacturing nonconformance was identified during the evaluation.A review of the complaint history review did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of the ifu and training manuals revealed no deficiencies.Per review of imagery of patient¿s anatomy, the right access vessel was revealed to have presence of calcification and tortuosity, as well as an mld of 5.4 which is slightly less than recommended (5.5mm for 14f esheath).Tortuosity can create a challenging pathway for delivery system insertion through sheath, while calcification and undersized mld can restrict the sheath from proper expansion; both of which can lead to increased push forces necessary to advance the delivery system through the sheath.Per training manual, ¿push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification¿.As such, available information suggests that patient factors (access vessel tortuosity/calcification/undersized mld) likely contributed to the complaint event.Per report, the access vessel was noted to have presence of calcification.Calcification 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 is more susceptible to tearing during advancement or retrieval of the delivery system.As reported, ¿while advancing the valve, the valve was stuck in the right common iliac artery due to a tine from the valve frame was caught on the sheath and transected the iliac¿.With increased push force, it is likely that excessive device manipulation occurred in attempt to overcome the experienced insertion resistance, causing the crimped valve strut to catch onto the sheath.Per training manual, ¿if push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system¿ and ¿do not over-manipulate the sheath at any time¿.Additional manipulation potentially further damaged the valve to bend the inflow struts outwardly and make it more susceptible to catching onto other surfaces such as the sheath liner.The interaction between the altered profile of the valve and the excessive device manipulation to counter the resistance may have contributed to the liner tear, liner strands observed on the sheath.As such, available information suggests that patient (access vessel calcification) and procedural (valve strut interaction; excessive manipulation) factors likely contributed to the liner torn and liner strand.As the access vessel was noted to have presence of calcification, calcified nodule(s) likely made contact with the sheath during insertion or retrieval of the sheath.Calcification can damage the hdpe shaft and strain relief of the sheath and create punctures.As such, available information suggests that patient factors (access vessel calcification) likely contributed to the reported sheath shaft damaged.A corrective / preventive action (capa) has previously been initiated to capture further investigation and corrective / preventative action activities related to the resistance during delivery system insertion and valve frame damage for s3u commander delivery system configuration.  a product risk assessment has also been initiated to assess patient risks.

Manufacturer Narrative

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

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10203572
• MDR Text Key: 197569173
• Report Number: 2015691-2020-12317
• 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
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1