MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26A

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Material Deformation (2976); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Event Description

Edwards received notification from a territory manager that during a transfemoral tavr, there was resistance between the valve/delivery system and the esheath, resulting in a bent valve strut.As reported, there was difficulty advancing 26mm valve/commander delivery system through 14fr sheath at access site.The sheath became kinked in fatty tissue between skin and arterial access along with unfortunate patient movement and discomfort, preventing the valve from advancing further into the artery.The loader able to be fully inserted into the sheath/sheath housing.The sheath was inserted at a steep angle.A portion of the valve stent became bent and protruding, making it impossible and dangerous to advance.The sheath was damaged and compromised.The decision was made to remove the entire system and esheath and prep a fresh, undamaged system.The second sheath/commander and valve were delivered without issue and the patient left the room in stable condition.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The valve was returned crimped on the 26mm commander delivery system.The outflow side of the valve was inside the distal end of loader tube.The valve had two (2) bent struts seen at inflow.All struts exposed through skirt, and it was normal after crimped and used.Post valve expansion showed: one bent strut at inflow, near to the c1 commissure.The other one was self-corrected.The frame was distorted and slightly canted.All struts remained exposed through skirt.The valve leaflets wrinkled and dehydrated due to storage condition (prolong crimping) during the return handling process.The device history record (dhr) was reviewed and the work orders did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to this event.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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.The complaint frame damage was confirmed through the device evaluation.No potential manufacturing non-conformance were identified.Review of the dhr, lot history, and manufacturing mitigations did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.As reported, 'there was difficulty advancing 26mm valve, commander through 14fr sheath at access site.The sheath became kinked in fatty tissue between skin and arterial access along with unfortunate patient movement and discomfort, preventing the valve from advancing further into the artery.The loader able to be fully inserted into the sheath housing.The sheath was inserted at a steep angle.A portion of the valve stent became bent and protruding, making it impossible and dangerous to advance.The sheath was damaged and compromised'.Per additional information, the access vessel had tortuosity and calcification.Per training manual, 'push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification', 'if push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the valve and delivery system', and 'do not over-manipulate the sheath at any time'.The presence of tortuosity and/or calcification along with high insertion angle can create a challenging pathway during delivery system advancement through the sheath leading to resistance, and subsequently causing the sheath to kink.In such condition, attempts to further advance the delivery system through the sheath can cause damage to the valve strut as seen in.As such, available information suggests that patient factors (tortuosity, calcification) and/or procedural factors (excessive device manipulation, steep insertion angle, and kinked sheath) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.A product risk assessment was previously performed per management discretion to assess the risks associated with high push force of the sapien 3 ultra valve with the commander delivery system and esheath configuration.In addition, a capa was previously initiated to capture further investigation and any possible corrective or preventative action activities.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12146771
• MDR Text Key: 263117804
• Report Number: 2015691-2021-04024
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)220811
• 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
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

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: 08/11/2022
• Device Model Number: 9750TFX26A
• Device Catalogue Number: N/A
• Device Lot Number: 7601721
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1