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

Model Number 916ESA

Device Problems Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906)

Patient Problems Laceration(s) (1946); Vascular System (Circulation), Impaired (2572)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

This is two of two manufacturer reports being submitted for this case.This report represents the sheath used in the case.Please reference related manufacturer report no: 2015691-2018-04862, (b)(4).The investigation is ongoing.

Event Description

During implant of a 29mm sapien 3 valve in the pulmonic position via transvenous approach, while crossing, there was resistance felt in the tricuspid valve.The wire may have been caught in the cords of the tricuspid valve, resulting in the resistance while crossing.The valve and delivery system were attempted to be crossed 3 times before it was decided to abort the procedure.While pulling the valve into the sheath, the sheath kinked and caused a laceration in the inferior vena cava (ivc).The valve was deployed in the ivc and the delivery system and sheath were able to be removed.Covered stents were placed to repair the laceration in the ivc.Per the report, post procedure a gi consult was requested to assess possible abdominal bleed.The patient was alive at the end of the procedure.

Manufacturer Narrative

Other relevant history was updated.The devices were not returned to edwards lifesciences for evaluation.Due to the unavailability of the relevant device, engineering was unable to perform any visual, functional or dimensional analysis.Withdrawal of the valve through the sheath most likely contributed to the damage caused to the sheath shaft.Per the report, while pulling the valve into the sheath, the sheath kinked.The training manual suggests to ¿ensure the thv is centered on the flex tip¿ during removal of a valve through a sheath.If the valve was not centered on the flex tip, it may have been more susceptible to catching on the sheath distal tip which may have resulted in the sheath shaft getting kinked.The ifu instructs users to ¿use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set.¿ calcification and tortuosity can interfere with the sheath upon insertion or removal, and can cause the sheath shaft to kink.Although a definite root cause is unable to be determined at this time, available information suggests that a procedural factor (valve catching on sheath distal tip) may have contributed to the complaint event.During manufacturing, the esheath shaft component was 100% inspected for the following: wrinkles, scratches, kinks, or bends; surface defects, protruding, missing material, dents or cuts; cross linking across liner; witness lines; holes or tears on the strain relief; remnant lines, seam separation, stress line; flash and excess material.During final inspection, the esheath underwent 100% inspection for the following: verify the tip id dimensions; visually inspect for wrinkles, kinks, bends, or mechanical damage; visually inspect for flash and excess material; visually inspect tip interface; visually inspect tip for presence of scoring and proper scoring.After sterilization, the lot underwent product verification (pv) testing on a sampling plan.All samples must pass pv testing in order for the lot to be released.These manufacturing inspections support that proper inspections are in place to detect issues related to the complaint event.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 sheath shaft ¿ kinked, bent was unable to be confirmed due to the device not being returned.A manufacturing non-conformance was unable to be determined.However, a review of complaint history revealed no indication that a manufacturing non-conformance would have contributed to the complaint.A review of manufacturing mitigations additionally supports that the sheath has proper inspections in place to detect issues related to the reported event.Available information suggests a procedural factor (valve catching on sheath distal tip) may have contributed to the complaint event.No potential manufacturing non-conformances were identified.Additionally, since no labeling or ifu inadequacies were identified, and a review of the complaint history revealed that the occurrence rate did not exceed the november 2018 control limit for the applicable trend category, neither a product risk assessment, nor corrective or preventative action was required.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect (common device name, product code, pma number).A correction to fields d2 and g4 is being submitted in this supplemental report.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 8097106
• MDR Text Key: 128192970
• Report Number: 2015691-2018-04863
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Female