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

Model Number 85443

Device Problems Material Rupture (1546); Activation Failure (3270)

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

Event Date 09/09/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the procedure for fenestrated endograph, an icast stent was selected and deemed defective as the balloon popped upon inflation to expand the stent.

Event Description

N/a.

Manufacturer Narrative

Additional information: section d9 & h6.Investigation: this complaint reports a balloon leak.The user attempted to place an icast covered stent (p/n 85443) along with a fenestrated endograft and the balloon "popped" upon inflation.Pictures (attached) were provided which show the icast stent sticking partially out the end of an introducer sheath.Additional information was requested about the procedure, however the respondent was unable to provide any details about the patient or procedure.The stent and delivery system were returned along with the introducer sheath.The stent was partially deployed and dislodged from the balloon.It was partially sticking out of the distal end of the introducer sheath.The catheter and stent were removed from the introducer sheath.The balloon was inflated to 10 atm, immediately revealing a leak.The hole was located in the proximal transition zone of the balloon, just above the proximal ro marker and an image was taken under a microscope.Additionally, there were also some scratches/indentations in a line leading to the hole.These looked as if something had scraped along the cone of the balloon a short distance and then punctured it.The flow rate of the leak was measured and found to be 1.902 slmp.The details about the fenestrated endograft in place are not known, however these typically would be held in place by fixation barbs which would be capable of causing the damage seen on the balloon.The stent was likely being placed through one of the fenestrations where it is possible that the balloon came into contact with one of the barbs.It should also be noted that because the balloon had been partially inflated and the stent partially deployed, it would most likely not have been possible to pull the stent back into the introducer sheath if it had fully cleared it.Attempting to inflate the balloon while still inside the sheath could cause the balloon to push against the stent in such a way that the described damage may have occurred.Pinholes have also been attributed to the crimping process in the past, however the damage in this case does not resemble previously seen damage from crimping.Without images of the operation or more information from the customer it is not possible to know for certain the cause of the damage.A dhr review of the finished good and relevant subassemblies was completed.No evidence was identified to suggest a specific manufacturing step or equipment are the cause of this complaint.No evidence was identified to suggest materials, or any design changes of the device or relevant subassembly parts are related to this complaint.The ifu provides adequate instructions and warnings for proper use of the device and no evidence was identified to suggest it is related to this complaint.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.Based on the provided pictures and the device evaluation, the complaint and the device nonconformity are confirmed.The cause of the damage, however cannot be determined.It is not consistent with damage seen previously during manufacturing.The nature of the procedure and the position of the returned stent inside the introducer sheath suggest that operational context is the most likely root-cause.However the damage to this balloon does not resemble that seen previously in manufacturing.No evidence was identified to suggest that this complaint is related to manufacturing, design, materials, or instructions for use.The information provided by the customer and the device evaluation determined that 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: 17895505
• MDR Text Key: 325834029
• Report Number: 3011175548-2023-00190
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854435
• UDI-Public: 00650862854435
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85443
• Device Catalogue Number: 85443
• Device Lot Number: 495327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 78 YR
• Patient Sex: Male