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

Model Number	85444
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
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 the vascular team opened an icast stent and noticed that the stent was not securely attached to the balloon.The icast was not deployed.Stent came off the balloon during prepping.
Additional Manufacturer Narrative
The details provided about the alleged incident were the following: the complainant indicated that the stent that is crimped on to the balloon came loose prior to making patient contact while prepping the device for use.Saw that the stent was not securely attached to the balloon.The device in question was returned and evaluated to determine the root cause of the complaint.Upon opening the returned device it was noted that the stent had been shifted distally off the balloon by approximately.5cm.The stent was in good condition but was very blood stained, although the device had been claimed to have not had patient contact.The stent was removed off the balloon to expose the underlying balloon that was still in the folded state and did not appear to have seen positive pressure.The balloon shows evidence that the stent was properly crimped as the stent frame leaves very defined imprints of the stent frame on the surface of the balloon.The stent appears to have been fully crimped.A review of the device history records shows that this lot of catheters passed all quality and performance criteria including stent retention testing.This test result shows that the minimum tensile value seen was 8.5 newtons.This passes the stent retention requirement as detailed in part specification drawing ps010635-xxx revision ab.The stent retention must be 5.5 newtons or greater.This lot of catheters passed this requirement.Based on the event details and results of this investigation the complaint has been confirmed as the stent was loose on the balloon however the investigation could not conclude that the dislodgement of the stent was caused by the manufacture of the product.As the device was very blood stained and claimed to have not had patient contact the root cause cannot be determined.There is a possibility that the stent was mistaken for a stent protector as the stent is covered with a white ptfe covering, or was otherwise mishandled, however this cannot be confirmed.In this regard the root cause is impossible to define.There is no indication that the product was at fault or defective.The trend review was completed and there were no trending excursions.The corrective action (capa) review did not identify any related capa's.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 labeling review determined the device was used off-label.
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: 13006580
• Report Number: 3011175548-2021-01310
• Device Sequence Number: 17335655
• Product Code: JCT
• UDI-Device Identifier: 00650862854442
• UDI-Public: 00650862854442
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/20/2022

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: 05/15/2022
• Device Model Number: 85444
• Device Catalogue Number: 85444
• Device Lot Number: 446645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown