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

Model Number	85444
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/12/2019
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 physician attempted to deploy the stent through a bronchoscope and witnessed a 'distal only' balloon inflation within a distal tracheal bronchial stricture.The balloon, stent and catheter were removed with no adverse effect or complication to the patient.
Additional Manufacturer Narrative
Analysis: the device in question was returned and evaluated to determine the cause of the complaint.The details indicate that only the distal end of the stent opened during the attempted deployment of the stent.Upon review of the returned stent it was clear that only one end of the stent had opened as one end was opened and crushed and the other end still very much un-deployed.There is an abrupt stop in the expansion of the stent.The balloon and stent deployment is designed to open in what is called a ¿dog bone¿ effect as both the proximal and distal balloon cones open simultaneously.If the stent was fully unrestrained during the deployment the expectation would be that both balloon cones would have opened thus deploying the stent.If only the distal end of the balloon opened as mention in the complaint details the stent would have flared only on the distal end of the stent and ultimately pushed the balloon back into the bronchoscope as the balloon opened unrestrained.This was not the case with the returned product.The proximal end of the stent was clearly not expanded and had been restricted.It appears as if the stent had not fully exited the bronchoscope prior to attempting to deploy the stent.An image of the stent is provided.The balloon was in perfect condition and fluid was seen filling the balloon from the two inflation ports that are located inside the balloon within the catheter shaft.Both inflation ports were present and patent.A full review of the catheter lot history records was performed.Below is an overview of the quality and performance criteria that every lot of icast covered stent systems is tested to.This inspection requires that the catheter lot must pass the following: ability of the stent and delivery system to be passed through the labeled introducer sheath (6fr).Ability to deploy the stent at nominal pressure (8atm).Ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.Ability of the delivery system to withstand 5 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).In addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: balloon hole skive dimensional verification.Stent securement testing.Proximal balloon weld tensile testing as detailed above.Distal tip tensile testing.Catheter leak check this lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Conclusion: based on the details of the complaint and the investigation results of the actual device in question, the icast covered stent did not completely exit the bronchoscope prior to attempting to deploy the stent restricting the proximal end of the stent from opening.The product that was returned functioned properly.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected a.3 - gender unknown.
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 03054
• MDR Report Key: 8910436
• Report Number: 3011175548-2019-00891
• Device Sequence Number: 13524509
• Product Code: JCT
• UDI-Device Identifier: 00650862854442
• UDI-Public: 00650862854442
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2019

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
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 02/10/2021
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/26/2019; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRONCHOSCOPE BF-1TH190; BRONCHOSCOPE BF-1TH190
• Outcome Attributed to Adverse Event: Required Intervention