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

Model Number 914ESA

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4) this is two of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-00269.  (mdr# (b)(4)).Investigation is ongoing.

Event Description

As per report from the field clinical specialist (fcs), during a tf tavr procedure of a sapien 3 ultra valve implanted in the aortic annulus with left side access, the balloon on the commander delivery system ruptured after successful deployment of the valve.  the delivery system was coaxial and retracted into the esheath, but the distal tip/ partial balloon was caught just above the iliac bifurcation and would not retract into the sheath, as the balloon ruptured transversely and flared/enfolded over the distal tip.The physician tried to remove the delivery system but was unable to retract the delivery system into the esheath.After multiple attempts to resolve the issue, it was decided to call vascular surgery, and the delivery system was surgically removed.After the delivery system was withdrawn from the esheath, it was noted that the distal end of the sheath was "split".  the patient was stable post vascular surgery retrieval and repair.  the delivery system was retained by the hospital for pathology review.

Manufacturer Narrative

This is two of two manufacturer reports being submitted for this case.Please reference manufacturer report no: 2015691-2021-00274.  mdr# 2020-15105-02 , second complaint.

Manufacturer Narrative

The following report fields have been updated due to additional information received: g3, h6.No devices were returned for evaluation, as the hospital required the delivery system be sent to their pathology for review.There were no relevant photographs, videos, or imagery were provided for review.A device history record (dhr) review did not reveal any issues that could have contributed to this event.A lot history review was performed and revealed no other similar complaints.The instructions for use (ifu) /training manuals for esheath, commander, and edwards device preparation were reviewed for guidance/instructions.There were no ifu/training deficiencies identified.All inspections were conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.During the manufacturing process the esheath final assemblies were 100% visually inspected by both manufacturing and quality for the following: verification of shaft dimension and distal tip dimension, tip visual inspection, protruding material (serrated transition, holes, rough surface), excess material, scratches in liner expansion pathway, tears on tip, missing c-marker band, amongst other inspections.These inspections during the manufacturing process support that it is unlikely that a defect in manufacturing contributed to the event.The complaint was unable to be confirmed due to the unavailability of the returned device or procedural imagery/photographs.As the device was not returned, engineering was unable to perform visual inspection, functional testing, or dimensional analysis.Therefore, a manufacturing nonconformances were unable to be determined.A review of manufacturing mitigations, dhr review, and lot history review did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.As reported event, the balloon burst.A balloon burst could have created difficulty withdrawing the delivery system into the sheath.Training manual procedure states, "do not force if resistance is met near or at the sheath tip".If excessive force was applied during the retrieval of delivery system (altered balloon profile), it could lead to the reported sheath distal tip damage.As such, available information suggests that procedural factors (excessive device maneuvering during retrieval of balloon burst through sheath) may have contributed to the complaint.However, a definitive root cause could not be determined at this time.There were no manufacturing nonconformances identified during evaluation.No labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action nor product risk assessment is required at this time.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.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 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: 11388150
• MDR Text Key: 242635378
• Report Number: 2015691-2021-00274
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: 914ESA
• Device Lot Number: 63310831
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention