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

Model Number 9610ES16

Device Problems Material Puncture/Hole (1504); Failure to Align (2522); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.This report is two of two manufacturer reports being reported for this case.Please reference related mfg.Report no.2015691-2021-01653.

Event Description

As reported by german affiliate, during implant of a 29mm sapien 3 valve, in the aortic position, by transfemoral approach.The valve alignment was not possible done properly due to the anatomy of aorta and the difficulty during the gross and fine adjustment.Frame damage of the valve was noted, and a decision was made to retrieve the valve into esheath and remove it as a single unit.The patient is stable.There was no injury reported.A new valve was implanted without issue.From pictures provided the sheath liner was delaminated.The device will be returned for evaluation.

Manufacturer Narrative

This report is 3 of 3 being submitted for this complaint.Reference mfg.Report no.2015691-2020-02109 and 2015691-2020-01653.The esheath was returned to edwards for evaluation.Visual inspection revealed the following: sheath liner circumferentially delaminated and bunched, liner delamination was 4.5 inchese from the distal tip, c marker band was present, kink at the distal tip likely from manipulation by the operator, two punch marks near distal tip at kink junction and minor sheath distal tip damage.Photos were provided and revealed sheath shaft appeared punctured, no kink visible, c marker band intact, sheath liner delaminated and bunched, and minor sheath distal tip damage.Functional or dimensional testing was not performed due to the condition of the returned sheath.During the manufacturing process, visual inspections and tests are performed throughout the process.During esheath assembly and sheath shaft component the sheath is visually inspected for defects.During manufacturing, proximal expansion the sheath is 100 percent visual inspected for seam separation.During final assembly, the esheath is 100 percent visually and dimensionally inspected by both manufacturing and quality for defects.In addition, after sterilization the sheath is tested and inspected on sample devices from each lot underwent product verification (pv) testing.The samples were inspected for expansion force testing and visual inspection of the sheath for abnormalities both before and after expander insertion force testing.No failures occurred during product verification testing and the lot was released.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot of history record review was performed and did not reveal any related complaints.The esheath ifu, the s3 commander preparation training manual, and the procedural training manual were reviewed.The procedural training manual provides guidance on delivery system removal.Completely unflex the delivery system, ensure the flex tip is still over the triple marker, ensure the balloon lock is locked, ensure the balloon is completely deflated, pull the entire delivery system through the sheath, and maintain guidewire position in the aorta.In addition, the procedural training manual provides guidance on thv retrieval through sheath.Thv can be retrieved through sheath only before thv deployment (still crimped), ensure the thv is centered on the flex tip, ensure delivery system is locked, verify the flex catheter is completely unflexed, retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip, ensure the edwards logo on the sheath handle is facing upward, and withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.The crimped thv aligned on the balloon is larger than the crimped thv off the balloon so take care if deciding to retrieve the system through the sheath.Do not force the thv into the sheath, if resistance is felt, the thv may be caught on the sheath tip, stop, advance thv past the sheath tip and ensure thv is centered on the flex tip and rotate the delivery system before trying again.No ifu or training deficiencies were identified.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 complaints for failure sheath liner delamination and failure sheath punctured were confirmed based on the provided imagery and visual inspection of the return device.Investigation of the device, dhr, lot history, and complaint history revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supported that the sheath has proper inspections in place to detect issues related to the reported event.No ifu/training manual deficiencies were identified.As reported per case notes, "a frame damage was detected, so it was decided to retrieve the valve into esheath and remove it as a single unit".The alleged liner delamination and sheath shaft puncture were confirmed based on the imagery provided by the site and the presence of the liner delamination and sheath shaft puncture, on the returned device.Due to the retrieval of the damaged valve, excessive force was likely applied, which likely resulted in the crimped valve strut catching within the liner leading to its delamination.As the valve did not enter the liner (rather delaminated it), the exposed bent valve strut likely interacted with the shaft, puncturing the sheath.In this case, available information, therefore, suggests that procedural factors (excessive device manipulation, valve strut caught on liner, bent valve strut) may have contributed to the complaint event.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no product risk assessment no corrective or preventative action is required at this time.

• 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: 11414070
• MDR Text Key: 239708960
• Report Number: 2015691-2021-01654
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

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: 08/31/2022
• Device Model Number: 9610ES16
• Device Lot Number: 63382206
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1