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

Model Number 9610ES14

Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528); Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 02/26/2024

Event Type  Death  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by an edwards france affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, there were difficulties trying to advance the commander delivery system and valve through the esheath beyond the right external iliac artery.The valve did not exit the tip of the esheath and was observed to be angulated on imaging (without damage or distortion of the valve).It was decided to retrieve the valve through the esheath, but on imaging, the pusher was noted to be pulled back creating a gap between the pusher and the valve.Therefore, the decision was made to remove the devices (esheath and commander ds with valve) as a unit, but this was unsuccessful.It was believed that the valve had exited the side of the esheath causing vascular damage.Bav was performed to help alleviate the aortic stenosis.An abdominal cutdown was performed and the patient remained stable with medication to maintain blood pressure.An abdominal aortogram showed no flow down the right leg.With effort, the delivery system with esheath were attempted to be removed together, but the valve remained inside the patient caught in the right external iliac artery.The esheath and delivery system were removed, and there was no bleeding or extravasation observed on aortogram.When reviewing the retrieved device, it was noticed that the delivery system tip and balloon had embolized.The patient then became hypotensive and cpr was started.Imaging showed there was little to no blood being pumped out of the right ventricle and almost no cardiac output.The patient had lost about 2l of blood from the cutdown and received 4 units of blood and fluids iv.The return of perfusion of the leg created lactate and potassium wash out returning to the heart, causing a drop in blood pressure which potentially aggravated the right ventricular dysfunction.After about 40 minutes of cpr, the patient passed away.As per medical opinion, the death was related to the ischemic spiral caused by the return of blood flow to the right leg creating the wash out effect, poor right ventricular ejection, and little to no reserve related to poor right ventricle and critical aortic stenosis, complicated by the transfer from sedation to intubation and stiff arteries due long term dialysis of 20 years.

Manufacturer Narrative

Additional information added to a2, a3, b5, b7, and h6.

Event Description

Per pre-decontamination evaluation of the returned devices, the esheath distal tip was observed to be split.

• 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: 18956332
• MDR Text Key: 338302154
• Report Number: 2015691-2024-02194
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103191219
• UDI-Public: (01)00690103191219(17)250327(11)230328
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Device Lot Number: 64965058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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; Death
• Patient Age: 79 YR
• Patient Sex: Male