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

Model Number 9755RSL29A

Device Problem Material Deformation (2976)

Patient Problem Perforation of Vessels (2135)

Event Date 09/07/2023

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs), during a valve in valve procedure with a 29mm sapien 3 ultra resilia in a preexisting 26mm sapien 3 ultra valve for paravalvular leak (pvl) , the team attempted to insert the 29 resilia on a 29mm commander delivery system through a 16fr esheath plus and the system got stuck inside of the sheath just above the proximal common iliacs (left side).There appeared to be a strut catching (bent strut) the inside of the sheath which was preventing the system from advancing the rest of the way through the sheath.After multiple attempts the team decided to take everything out together.As the sheath was being removed with the commander and valve inside of it the team felt a lot of friction and realized that the patient's pressure was dropping.Following an angiogram, they realized that the external iliac and distal to that was perforated.They called vascular surgery for support following the deployment of an occlusion balloon in the proximal left iliac.When vascular surgery arrived, they attempted to remove the rest of the system and sheath.Part of the femoral artery came out with the sheath and system.They quickly deployed a covered stent and cutdown to sew the covered stent to the left superficial femoral artery.The patient was stable following the procedure.No valve was deployed.The ic was planning on implanting a 29 resilia ultra inside and just below the 26 s3u to flare the outflow of the valve out to resolve the moderate pvl.No valve was ever deployed.Per the fcs, the initial reporter did not allege the edwards devices were deficient in some way.The perceived root cause of the pvl of the 26mm sapien 3 ultra valve was under sizing and bulky annular and lvot calcium.With the system, the expansion tool was used, the loader was able to be fully inserted into the sheath/sheath housing and the sheath was not inserted at a steep angle.The delivery system was at the partially expandable white portion and again in the blue portion about 3 inches from the end when resistance was noted.Per the fcs after removal of the devices it was noted the 16f sheath had split apart in a longitudinal tear.The perceived root cause of the iliac perforation was trying to withdraw with the system.Per the fcs, the patient was given heparin.The fcs confirmed the linear tear was down the blue portion of the esheath.The valve never made it through the end/tip of the sheath.It was believed that the perforation was due to the bent valve which may have caused the linear tear, which in return perforated the vessel possibly on the way out while attempting to retrieve the system.The devices are being returned for further evaluation.

Manufacturer Narrative

This is one of three reports being submitted for this case.Please reference manufacturer report no.2015691-2023-16393 and 2015691-2023-16394.The investigation is ongoing.H3 other text : device not returned.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The complaint for frame damage and subsequent perforation of vessels was confirmed through evaluation of the returned device and provided imagery.A review of the dhr did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.An existing technical summary captures the root cause analysis for complaints evaluated for resistance with delivery system and valve frame damage as a result from increased push force.The root causes identified in technical summary were reviewed and the following were identified as applicable to this event.Tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen during advancement, leading to resistance.Per imagery, the patient's access vessel has present of tortuosity.Excessive device manipulation/high push force can lead to the valve struts interacting with the sheath shaft and resulted the strut damage at the valve inflow side.As reported, ''the team attempted to insert the 29 resilia on a 29mm commander delivery system through a 16fr esheath plus and the system got stuck inside of the sheath just above the proximal common iliacs (left side).There appeared to be a strut catching (bent strut) the inside of the sheath which was preventing the system from advancing the rest of the way through the sheath.'' calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.As per imagery, calcification was present in the patient's left access vessel.Undersized vessels (e.G.Due to anatomical variation, pre-existing stent or graft, scar tissue, or fibrosis) can create a restricted pathway or constrained condition resulting in challenging pathway during delivery system advancement leading to resistance.Per imagery review, patient has undersize vessels.The presence of the above factors can create challenging pathway during delivery system advancement, leading to resistance.More than one of these factors can compound to further exacerbate the patient/procedural conditions and increase the likelihood of encountering resistance during delivery system advancement through the sheath resulted in frame damage.The technical summary also outlines the extensive manufacturing mitigation in place to detect a defect or nonconformance associated with this issue.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.These inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.In addition, assessment of the detailed instructions for use (ifu), device preparation training manuals, and procedural use training manual revealed no identifiable deficiencies.These mitigations (from manufacturing and the ifu/training manual) as identified in the technical summary are still in place to mitigate this issue.Based on available information, investigation suggests that patient factor (tortuosity, calcification, undersized vessel) and/or procedural factors (excessive device manipulation, high push force) may have contributed to the reported event.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 nor preventative actions (pra) are required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 17837873
• MDR Text Key: 324520057
• Report Number: 2015691-2023-16397
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215823
• UDI-Public: (01)00690103215823(17)260208(11)2302092110373273
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9755RSL29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male