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

Model Number 914ESPA

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528)

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

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Event Description

As reported by field clinical specialist (fcs), during a procedure to implant a 23mm sapien 3 ultra, during post dilation the non-edwards balloon ruptured.The balloon was fully inflated for a second, then it burst, folded on itself and would not come out through the sheath.The esheath was split about 1 inch back from the tip at the distal end.A surgical cutdown was performed with success.No blood transfusion was required and the closure was successful.Photos provided by the fcs revealed that the liner was delaminated.

Manufacturer Narrative

H2 h6 updated the esheath was not returned; therefore, a visual inspection, functional testing, dimensional testing was not performed.Imagery was provided by the site and revealed the following: calcification and tortuosity observed in patient access vessels.The nonedwards balloon was ruptured and stuck in the sheath with the sheath liner fully and circumferentially delaminated.A device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.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.A lot history review was performed and revealed no other complaints relating to failure sheath liner delamination and withdraw catheter and valve through sheath nonedwards device withdrawal inability through esheath.A complaint history review on confirmed device complaints for failure sheath liner delamination identified patient factors: tortuosity as a potential root cause applicable to the event.A complaint history review was performed with the code withdraw catheter and valve through sheath nonedwards device withdrawal inability through esheath, however, no complaints were identified.This event reports a negative device interaction with a non edwards device.There was no evidence of product nonconformances or labeling/ifu inadequacies identified in the evaluation.Edwards continues to monitor complaint history on a monthly basis.The following instructions were reviewed; commander instruction for use (ifu) and procedural training manual.No ifu/training deficiencies were identified.The complaints for failure sheath liner delamination, and withdraw catheter and valve through sheath nonedwards device withdrawal inability through esheath were confirmed based on returned imagery.As no device returned for evaluation, no visual inspection, functional testing, or dimensional analysis was able to be performed.As such, a manufacturing nonconformance was unable to be determined.However, review of dhr, lot history, and complaint history did not identify any nonconformances.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormities during device unpacking or preparation were noted.As reported, as reported by field clinical specialist (fcs), during a procedure to implant a 23mm sapien 3 ultra, during post dilation the nonedwards balloon ruptured.The balloon was fully inflated for a second, then it burst, folded on itself and would not come out through the sheath.The esheath was split about 1 inch back from the tip at the distal end.A surgical cutdown was performed with success.No blood transfusion was required, and the closure was successful.Photos provided by the fcs revealed that the liner was delaminated.It is likely that the increased profile of the burst balloon resulted in the inability to withdraw the nonedwards inflation system through the sheath.Returned 3mensio also confirmed that calcification and tortuosity was present in the patient access vessel.Patient factors such as calcification and tortuosity can create suboptimal angles leading to nonaxial alignment and further increase retrieval difficulty.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (retrieval of burst balloon) likely contributed to the complaint event.Since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions (capa) are required.Since no product non conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment (pra) escalation is not 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: 15027642
• MDR Text Key: 295968093
• Report Number: 2015691-2022-06795
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240323(11)2203242164291387
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: 914ESPA
• Device Lot Number: 64291387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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