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

Model Number 914ESPA

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

Patient Problem Rupture (2208)

Event Date 03/12/2024

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the field clinical specialist, this was a do no harm case.Right femoral esheath access was gained without issue.While advancing the ds with valve through the esheath, the patient blood pressure dropped to 30/20.Angiogram revealed rupture of distal ao and possibly l iliac.Ds removed and life saving measures, including evar attempted, but patient never stabilized.The valve was not deployed.The site doesn't allege that there was something wrong with the sheath, but one physician questioned if there was anything abnormal about the ''splitting of the esheath+'' and asked for it be reviewed.The patient was not alive at the end of the procedure.The valve was not successfully implanted.There was no use error that lead to any negative outcomes or patient injury.There was no device malfunction/difficulty using the device during case.

Manufacturer Narrative

Correction to b5 and h6 and update to b4, g3, g6, h2 based on new information received from a voluntary medwatch and follow up information from fcs.Investigation is ongoing.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2024-03165.Information regarding this case was received during follow up from field clinical specialist, but also voluntary medwatch, mw5153349.

Event Description

As reported by the field clinical specialist, this was a do no harm case.Right femoral esheath access was gained without issue.While advancing the ds with valve through the esheath, the patient blood pressure dropped to 30/20.Angiogram revealed rupture of distal ao and possibly l iliac.Ds removed and life saving measures, including evar attempted, but patient never stabilized.The valve was not deployed.The site doesn't allege that there was something wrong with the sheath, but one physician questioned if there was anything abnormal about the ''splitting of the esheath+'' and asked for it be reviewed.The patient was not alive at the end of the procedure.The valve was not successfully implanted.There was no use error that lead to any negative outcomes or patient injury.There was no device malfunction/difficulty using the device during case.Additional information from the fcs, confirmed that there was difficulty removing the delivery system and valve into the esheath.Additionally, the valve exited through the tip of the esheath.A voluntary medwatch was received regarding this case.As reported by the site, ''the balloon and valve were advanced into sheath over the wire.Initially push forces were somewhat tight but no more than usual.There was a sudden reduction in the level of resistance and delivery of catheter could be seen extending into the left side of the abdomen outside the normal course of abdominal aorta.There was a sudden loss of blood pressure.Surgeon removed delivery catheter but valve was no longer mounted on the catheter, exchanged the edwards sheath for a 14fr medtronic sheath.Despite the valve never having advanced past the distal end of the sheath the valve somehow remained in the patient.A reliant balloon was placed in proximal portion of abdominal aorta to assist w/ hemostasis.Vascular surgery was called to assist.Hemostasis was attempted with an endograft.Resuscitation efforts were carried out, patient was pronounced deceased 40 minutes later.''.

• 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: 19051240
• MDR Text Key: 339490470
• Report Number: 2015691-2024-02610
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)251024(11)231025
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• 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: 65385821
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male