MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER; INTRODUCER, CATHETER

Model Number 9610ES14

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 06/23/2022

Event Type  malfunction  

Event Description

As reported by an edwards brazil affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, the operator felt the valve 'jump' and go quickly into the abdominal aorta after the valve passed the distal end of the esheath during insertion of the delivery system and valve.Upon removal of the esheath, a rip was observed at the tip.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

Note: this mdr was originally submitted within the 30-day timeline, but due to a technical issue experienced during the submission process, acknowledgment 3 was not received.The mdr was confirmed to be transmitted properly, as we received acknowledgement 1 and 2, but this issue could not be resolved through the esg help desk, so this mdr has been resubmitted.Please reference esg and cesub support reference numbers: (b)(4).The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done, and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.Images were provided and the following observed: esheath distal tip torn at the distal liner edge.The tip opened along the axial score line.Shaft stretching observed along the tear.Sheath liner appears expanded as designed, the esheath slightly curved from use, procedural cine shows the delivery system with crimped valve 'jumping' forward during advancement.However, the sheath distal tip is not visible in the imagery.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no 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 complaint for esheath distal tip torn was confirmed per evaluation of the provided imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the complaint description, 'when the esheath was removed, it was observed that there was a rip in the tip.As per medical opinion, event happened after the valve passed by the distal end of the esheath, because when it got out of it, physician felt the valve 'jumped' and went quickly into the abdominal aorta.It was mentioned that it could happened that any part of the valve touched the esheath and caused the damage'.Per evaluation of the imagery, the sheath distal tip was observed to be torn radially along the distal edge of the liner.The failure mode is characteristic of sheath tip tear events as described in a previously initiated product risk assessment to investigate the cause and assess the risk associated with improper expansion of the sheath tip.While a definitive root cause was unable to be determined, previous investigation indicated that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to the distal tip tear.As such, the failure mode may be related to improper expansion of the sheath tip during thv advancement.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: EDWARDS ESHEATH INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• 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: 15062209
• MDR Text Key: 304333456
• Report Number: 2015691-2022-06861
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1