MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS I-CAST; ILIAC COVERED STENT, ARTERIAL

Model Number 42838

Device Problem No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

During the case the icast balloon failed.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: b5, d9,& d10 correction: h6.

Event Description

Additional information, it was during the removal of the stent through the tourguide shealth the stent become dislodged from the balloon in the valve of the shealth.During the removal of the icast due to not tracking in the tortuous anatomy.

Manufacturer Narrative

Corrected information: d2b - product code, d4 model # and catalog #, & g4 - pma/510k.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Additional information: section h6 investigation summary: the details provided indicate that during the removal of the icast stent through the tourguide sheath, the stent become dislodged from the balloon in the valve of the sheath.Further details were provided with the complaint.The case was a physician modified endograft procedure with the target being the superior mesenteric artery.Response from the complainant also mentions that the anatomy of the patient was tortuous and that the delivery of the stent required excessive manipulation.There was no indication of a balloon leak or burst during the procedure.The stent was removed due to not tracking in the tortuous anatomy.The device in question was returned on 08 mar 24.Upon initial inspection the stent was no longer on the balloon confirming the complaint.The condition of the stent shows that the stent was still in its original crimped and undeployed state but had been bent significantly.The covering of the stent was in good condition and there were no signs of deployment or partial deployment.The balloon of the catheter was still in its folded position and also showed no signs of positive pressure that would have affected the stent¿s ability to maintain its crimped position on the balloon.The balloon showed clear signs that the stent was properly crimped as the stent frame outline could clearly been seen on the surface of the balloon.These impressions on the surface of the balloon are indicative of a properly crimped stent.The catheter shaft itself was in good condition and showed no signs of damage.The icast instructions for use aw009603 specify the following ¿do not pull an unexpanded stent back through a guiding catheter or sheath (see directions 4.0 removal of unexpanded stent.¿ ¿4.0 removal of unexpanded stent extreme caution must be used when removal of an unexpanded or partially expanded stent is necessary.The stent/delivery system should not be withdrawn until the proximal end of the stent is aligned with the distal tip of the introducer sheath.The sheath and the stent delivery system should then all be removed as one unit.After removal, the icast covered stent system should not be reused.¿ the details provided suggest that the tortuosity of the patient¿s anatomy was the main factor of the icast being withdrawn back into the introducer sheath and as such the complaint cannot be confirmed to be the fault of the device.Further, the icast device was used in a non-indicated anatomy.The device is indicated for use in the native common and/or external iliac arteries.The icast stent delivery system has not been tested or evaluated for use in the superior mesenteric artery.The device history records review did not identify any non-conformances.All product quality and performance requirements were met.There was no on demand maintenance of associated manufacturing or test equipment identified around the time of manufacture and all equipment was in calibration.No significant design, material, procedural or process changes around the time of device manufacture have been identified.The complaint history shows that there have been 7 other complaints related to difficulties delivering the stent while tracking to the target area.All were part of procedures related with aortic endografts where the target was the celiac or mesenteric artery.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.The instructions for use provide adequate instruction and warnings in regard to pulling an unexpanded stent back through the introducer sheath.Based on the information provided in the complaint, there is no evidence to conclude that the device was faulty or manufactured improperly.As the case was a physician modified endograft procedure with the target being the superior mesenteric artery and the anatomy of the patient was tortuous and that the delivery of the stent required excessive manipulation operational context of the procedure was a contributing factor.Because the stent was withdrawn back though the introducer sheath against the instructions for use, the root cause is user error.

• Brand Name: STENTS I-CAST
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• 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: 18766579
• MDR Text Key: 336514123
• Report Number: 3011175548-2024-00068
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120003
• 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: 04/23/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42838
• Device Catalogue Number: 42838
• Device Lot Number: 499545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GORE VBX, TOURGUIDE SHEATH.; UNKNOWN.
• Patient Age: 52 YR
• Patient Weight: 75 KG