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

Model Number 9750TFX26A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a tf tavr procedure for a 26mm sapien 3 ultra valve, the valve appeared to have punctured the esheath and bent one of the valve tines backward.This was not realized until the valve was deployed.At this time it appears that no harm was caused to the patient.

Manufacturer Narrative

Correction to h6 based on additional information received.The device was not returned to edwards lifesciences for evaluation, however, a device history records review (dhr) did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.All inspections are conducted on 100% of the units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.During incoming inspection of the components, the valve frames are 100% dimensionally inspected and 100% visually inspected by both manufacturing and quality for scratches, fracture/cracks, rough surface, distortion, gap/void/notch, step, wavy cut, grinding, burrs and protrusion.During manufacturing, all sapien 3 ultra valve assemblies undergo 100% visual inspection for valve outer diameter.During the final assembly and prior to final packaging, the sapien 3 ultra valves are 100% inspected to ensure there was no damage to the valves from the handling.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The following instructions were reviewed: ifu commander delivery system with s3u thv, us, device preparation manual, and procedural training manual.Based on this review, no ifu/training deficiencies were identified.A complaint history review was performed for the complaint of frame damage, this reviewed revealed the complaint is unable to be confirmed.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 for frame damage was unable to be confirmed as no device or imagery was provided for evaluation.A review of manufacturing mitigations supports that the sapien 3 ultra valve had proper inspections in place to detect issues related to the complaint events.A review of ifu/training revealed no deficiencies.Due to no device being returned for evaluation, no visual inspection, functional testing, or dimensional analysis was able to be performed.As such, a manufacturing non-conformance was unable to be determined.A review of the dhr and manufacturing mitigation revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.As reported, 'the valve appeared to have punctured the esheath and bent one of the valve tines backward.This was not realized until the valve was deployed'.Additional noted that 'the difficulty experienced was that the push force required to push the valve through the sheath was higher than normal', and patient had minimal tortuosity and calcification.The presence of calcification and tortuosity access vessels can create a challenging pathway during delivery system (with crimped valve) advancement through the sheath, leading to resistance and high push force.In such condition, additional push force/device manipulation could lead to valve strut catch within the sheath and resulting in sheath puncture and bent strut.A capa has identified potential areas for s3u design/process improvement to mitigate against the failure.These patient/procedural conditions, in conjunction with the exposed apices of the crimped s3u thv, may increase the rate of frame damage.A capa has identified potential areas for s3u design/process improvement to mitigate against the failure.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.These patient/procedural conditions, in conjunction with the exposed apices of the crimped s3u thv, may increase the rate of frame damage.As such, available information suggests that patient factors (calcification/ tortuosity) and/or procedural factors (additional device manipulation) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Per management discretion, a product risk assessment was previously initiated to assess the risks associated with valve frame damage resulting from high push force of the commander delivery system with s3u through the esheath.A capa has been initiated to capture further investigation and corrective/preventative action activities related to the high resistance during delivery system insertion, and valve frame damaged for s3u commander delivery system configuration.

• 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: 11383097
• MDR Text Key: 234296662
• Report Number: 2015691-2021-01468
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)220901
• 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
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 9750TFX26A
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1