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

Model Number 914ESPA

Device Problems Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

Device not expected back.Investigation is ongoing.

Event Description

Per the field clinical specialist (fcs), during a valve in valve procedure for aortic insuffiency/aortic stenosis (ai/as), the original gradient was only in the high 20s.After a postdilation using a 23 true balloon, there was still an echo gradient of 15mmhg.Another postdilation was performed using a 24 true balloon in order to fracture the mosiac valve.During the inflation, the 24 true balloon ruptured and there were issues pulling the ruptured true balloon back into the esheath as the ruptured balloon caught on sheaths lining.The esheaths tip folded over itself and true balloon was stuck in the sheath.The operators tried for 3 hours to snare and get the true balloon free, but patient had to go to surgery to repair.

Manufacturer Narrative

The esheath plus was not returned; therefore, a visual inspection, functional testing, or dimensional testing was not performed.Imagery was provided by the site and revealed the following: calcification and tortuosity seen in patients access vessels.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no complaints related to the event withdraw catheter and valve through sheath non edwards device withdrawal difficulty through esheath and failure sheath damaged.As the complaints for withdraw catheter and valve through sheath non edwards device withdrawal difficulty through esheath and failure sheath damaged were unable to be confirmed, a complaint history review is not required.No device was returned and there is no evidence to support a manufacturing/design defect potentially contributing to the complaint, therefore a manufacturing mitigation review is not required.The following instructions for use (ifu) were reviewed; esheath+ introducer set, preparation manual, procedural manual.No ifu/training deficiencies were identified.A risk assessment was performed on the reported event and revealed no evidence of product non conformances or labeling/ifu inadequacies.The complaints for withdraw catheter and valve through sheath non edwards device withdrawal difficulty through esheath and failure sheath damaged were unable to be confirmed.As the device was not returned, engineering was unable to perform any visual inspection, functional testing or dimensional analysis.However, reviews of the dhr and lot history did not indicate presence of a manufacturing nonconformance.A review of the ifu and training manuals revealed no deficiencies.Furthermore, no abnormalities were observed during device unpacking or preparation.Per complaint details, during the inflation the 24 true balloon ruptured.There were issues pulling the ruptured true balloon back into the esheath as the ruptured balloon caught on sheath lining and the esheath tip became folded over itself and balloon got stuck in esheath.As a balloon burst was present, it is likely that the balloon burst altered the balloon profile making it more susceptible to catching on the tip of the sheath, contributing to withdrawal difficulties.Patient imagery also showed tortuosity in the patients access vessels.Tortuosity could have increased the withdrawal difficulties by creating suboptimal angles for withdrawal of the device.Withdrawal difficulties was then likely attempted to be overcome with excessive manipulation, furthering causing the sheath to become damaged.However, without knowing the exact damage to the sheath, this definitive root cause could not be determined.As such, available information suggests that patient factors (tortuosity) and/or procedural factors (balloon burst) may have contributed to the complaint event.Since no manufacturing nonconformances or labeling and ifu and training deficiencies were identified, no product nonconformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective and preventative actions (capa) nor product risk assessment (pra) escalation are required.

• Brand Name: EDWARDS ESHEATH PLUS
• 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: 15352396
• MDR Text Key: 299210534
• Report Number: 2015691-2022-07687
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240516(11)2205172164381121
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Lot Number: 64381121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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