MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS I-CAST; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85414

Device Problems Difficult to Remove (1528); Material Separation (1562); Separation Failure (2547)

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

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

During a physician-modified endovascular graft (pmeg) procedure case and after deploying the icast stent in the celiac artery the catheter separated completely approximately 4cm from the proximal marker on the balloon leaving the balloon portion and part of the catheter remaining in the celiac artery.The doctor then used a snare and was able to retrieve the remaining catheter and balloon system.The patient is doing fine.

Event Description

N/a.

Manufacturer Narrative

Investigation: during a pmeg case and after deploying the icast stent in the celiac artery the catheter separated completely approximately 4cm from the proximal marker on the balloon leaving the balloon portion and part of the catheter remaining in the celiac artery.The doctor then used a snare and was able to retrieve the remaining catheter and balloon system.The patient is doing fine.This complaint is in regards to the use of a 7mm x 38mm x 120cm icast covered stent in a physician modified endo graft procedure (pmeg) for use in the celiac artery.There were no fluoroscopic images provided that would have aided into the investigation.Questions were sent to the institution and were responded to and there is no indication that the balloon ruptured during deployment as the balloon was claimed to have been fully deflated and no blood was seen entering the inflation device and the balloon was also claimed to have been fully deflated under fluoroscopic imaging.The returned device was removed from its packaging and the balloon segment including the underlying catheter shaft had been separated from the main catheter shaft at the location of the proximal balloon weld confirming the complaint.The break appears to be where the proximal balloon weld ends and the un-welded portion of the balloon neck intersect.The balloon had been inverted on itself and was in very poor condition.The balloon had multiple areas where it had been damaged during the procedure.The distal tip of the catheter was still intact and the distal balloon weld was also still intact.Both the proximal and distal radiopaque marker bands had been displaced and the shaft buckled under the area to where the ro marker band was moved to distally.The balloon was in such poor condition that an assessment of the balloon integrity could not be accurately performed.There were multiple splits and tears on the surface of the balloon.A review of the device history records was conducted and this production lot of catheters passed all quality and performance requirements.Without more detailed information from the case including fluoroscopic images the investigation cannot confirm that the icast covered stent was at fault.A review of the device history records going back to the balloon subassembly level shows that there were no non-conformances noted and the product met all quality and performance requirements.Based on the review of the device history records there is no indication that a design, manufacturing specification, test method, manufacturing process, equipment or raw material was the cause of the complaint.As the device was used in conjunction with a physician modified aortic graft in the celiac artery it is likely that the balloon was damaged while withdrawing the balloon back toward the introducer sheath.In this regard the most likely root cause is operational context.

• Brand Name: STENTS I-CAST
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 15539958
• MDR Text Key: 301154250
• Report Number: 3011175548-2022-00274
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854145
• UDI-Public: 00650862854145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• 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
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2023
• Device Model Number: 85414
• Device Catalogue Number: 85414
• Device Lot Number: 455813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 366 KG