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

Model Number	85424
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
During a zfen case dr.(b)(6) was placing an icast 10x38x120 into the celiac artery and had some resistance.He then removed the complete icast stent and noticed that the stent had partially slide off the balloon but was still attached and removed completely from the sheath/body.A new stent was used successfully and the patient is doing well.
Additional Manufacturer Narrative
Investigation: during a zfen case dr.Han was placing an icast 10x38x120 into the celiac artery and had some resistance.He then removed the complete icast stent and noticed that the stent had partially slide off the balloon but was still attached and removed completely from the sheath/body.A new stent was used successfully and the patient is doing well.Additional information was also provided regarding the case.The cause of the withdrawal of the catheter was due to the resistance encountered during advancement into the celiac artery.The stent was also attempted to be withdrawn back through the introducer sheath undeployed.A review of the returned device was conducted.The stent was found loose in the bag and no longer on the balloon catheter and had been damaged during the withdrawal back through the sheath making an assessment of the diameter impossible.There was one spot on the stent that appeared to have been pinched with forceps.Likely from pulling the undeployed stent out of the introducer sheath.The introducer in this case was not returned.The catheter was returned and evaluated.The balloon was still in the folded position and showed no evidence that the balloon had seen positive pressure.The impressions of the stent frame were clearly visible on the balloon surface that are indicative of a properly crimped stent.The balloon was in good condition and showed no signs of damage.The catheter shaft was also examined.There was noticeable damage to the shaft 45cm from the manifold inflation bifurcation.The damage noted appears to have been caused by axial compression of the shaft due to excessive force being applied while trying to advance the catheter into the celiac artery.Based on the review of the returned device the investigation confirms that the stent was dislodged off the balloon.However, being that the stent was attempted to be withdrawn back through the sheath in the undeployed state against the instructions for use the complaint is related to user error and the operational context of the procedure.A review of the device history records going back to the balloon sub assembly level 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 13 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 489715 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 13.0 newtons.This exceeds this requirement.The finished good dhr 790236 review included a verification of the instructions for use quantity issued versus the amount of product manufactured.The device history record shows the manufacturing lot size was for 112 units.The job lot trace report shows that there were 112 instructions for use p/n 011570 issued to the work order and no scrap was reported for the ifu.This indicates that all ifu's were accounted for and placed in the pouch of the finished product.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 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.Based on the results of this investigation the investigation confirmed that the stent was dislodged however 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.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: section e1- hospital phone number.

• 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: 16340015
• Report Number: 3011175548-2023-00055
• Device Sequence Number: 17747328
• Product Code: JCT
• UDI-Device Identifier: 00650862854244
• UDI-Public: 00650862854244
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2023

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: 10/20/2025
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 490236
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 02/10/2023; 03/22/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/13/2023; 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG