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

Model Number	85405
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	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Stent came off balloon when pulling stent out of sheath.
Additional Manufacturer Narrative
Based on the details of the complaint provided the "stent came off balloon when pulling stent out of sheath." there was no other information provided.Multiple attempts were made to obtain more information regarding this case were made but not answered.There were also no images provided and the product in question was not provided for evaluation.Without the device in question or images from the case it is not possible to confirm the complaint.A review of the stent retention test data for this lot of catheters indicates that this lot passed all stent retention requirements.Per the part specification drawing ps010636-xxx ps,stent delivery system,otw,v12/icast,3l,5-10mmx32/38/59mm revision ad the out of box stent retention must meet or exceed 5.5 newtons.The test data of the three samples tested shows that the minimum force realized during this test was 17.4 newtons.This exceeds this requirement.The instructions for use of the product aw010835 revision aa specifically cautions against pulling an unexpanded stent back through the bronchoscope or endotracheal tube as dislodgement of the icast covered stent may occur.A review of the device history records going back to the sub assembly level where the balloon is formed shows that there were no non-conformances noted and the product met all quality and performance requirements.This includes the advancement of the crimped stent through the labeled introducer sheath and stent deployment of 20 catheter units without stent movement or stent deployment issues.The testing also conducted, as part of the product lot qualification is stent retention testing of three units.The stent retention test data as seen in the top assembly dhr 465723 for this lot of catheters indicates that this lot passed all stent retention requirements.Per the part specification drawing ps010636-xxx ps,stent delivery system,otw,v12/icast,3l,5-10mmx32/38/59mm revision ad the out of box stent retention must meet or exceed 5.5 newtons.The test data of the three samples tested shows that the minimum force realized during this test was 17.4 newtons.This exceeds this requirement.The labeling review determined that the device was used off-label in a vascular procedure.However, the instructions for use provided with the icast covered stent provides clear warnings and precautions related to vascular usage, as well as clear precaution and instruction against pulling an unexpanded stent back through the introduction device, noting this can lead to stent dislodgement.As such, the guidance for removal of an unexpanded stent was not followed.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.Based on the results of this investigation the cause of the stent dislodging off the balloon upon withdrawal was a direct result of operator error and the complaint cannot be confirmed to be the fault of the icast covered stent.H3 other text : device not returned.
Event or Problem Description
N/a.

• Brand Name: STENTS I-CAST
• 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: 12325648
• Report Number: 3011175548-2021-00847
• Device Sequence Number: 14588127
• Product Code: JCT
• UDI-Device Identifier: 00650862854053
• UDI-Public: 00650862854053
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 10/26/2023
• Device Model Number: 85405
• Device Catalogue Number: 85405
• Device Lot Number: 465808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2021
• 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: NOT PROVIDED; NOT PROVIDED
• Patient Sex: Unknown