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

Model Number	85453
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that an icast stent did not go through a 6 french sheath.It was noticeably thicker than icast's used in the past.It was removed and a new icast was used of the same size but different batch and it went through fine.
Additional Manufacturer Narrative
The product was not returned for evaluation and no pictures provided.Based on the details provided, prior to moistening/wetting, the stent met with resistance using a cook sheath, but after moistening/wetting, deployment was successful.As per icast instructions for use, preparations of the icast covered stent and delivery catheter states the following: ¿moisten the icast covered stent with saline.¿ ¿take caution if using the device with an introducer sheath.¿ as per cook medical introducers instructions for use, precaution and sheath introduction sections states the following: ¿before removing or inserting devices through the introducer, aspirate through the side-arm valve to clear the introducer, then flush with heparinized saline.¿ ¿using the side-arm of the valve, flush the introducer by filling the introducer assembly completely with heparinized saline.¿ ¿flush the dilator with heparinized solution.¿ a review of the device history records show that this lot of icast covered stent passed all quality and performance requirements without any non-conformances noted during the manufacture of the production lot of catheters and has not identified any material, design, manufacturing or equipment issues that would have contributed to the reported complaint.The product requirement document describes the requirement as "device must pass through standard bronchoscopes and endotracheal tubes without stent dislodgment or catheter damage.¿in this case, a sheath was used as the device was used in a vascular application.During lot qualification testing, introducer sheath compatibility was tested.Introducer sheath compatibility was tested by wetting the distal catheter shaft, including the stent, prior to passing the stent/catheter through a size 6 fr sheath.The test required that the stent remain between the ro markers when passing through the sheath and that the stent and catheter pass through the sheath without damage.No failures were identified for the test.Based on the details provided and correspondence indicating that prior to wetting the stent met with resistance, but after wetting deployment was successful, the complaint could not be confirmed.The most probable cause is that the stent met with resistance because the material was not wetted/moistened prior to use as required by icast instructions for use and cook medical introducers instructions for use.Based on the details of the complaint there is no evidence to conclude that the device was faulty.The product met all quality and performance requirements at the time of manufacture.The investigation has concluded that the product was not defective and therefore the complaint cannot be confirmed.H3 other text: not available for return.
Event or Problem Description
N/a.

• Brand Name: I-CAST COVERED STENT
• Common Device Name: 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: 12088463
• Report Number: 3011175548-2021-00717
• Device Sequence Number: 16981426
• Product Code: JCT
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2024
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 472008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown