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

Model Number	85453 - ICAST COVERED STENT 6MMX22MMX120CM
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Icast was introduced into patient and could not make the turn through the oscor sheath.When it was pulled back out the stent got caught in the hub of the sheath and was pulled off the device.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis: the device was returned and inspected to determine if the device in question was defective.Upon opening the returned device it was noted that the 16mm x 22mm stent was no longer crimped on to the balloon as mentioned in the complaint details.The stent was perfectly straight as was the underlying balloon.It was expected to be curved at a minimum as the case details mentioned the device could not make the turn into the renal artery.The returned device balloon surface was evaluated to determine if the stent was crimped properly during manufacturing.When the stent is crimped on to the folded balloon the stent frame leaves impressions on the surface of the balloon.The crimped stent impressions were clearly visible indicating that the stent was properly crimped during manufacturing.The icast covered stent delivery system manufacturing lot number was not provided.Below is a list 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/7fr) depending on size.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 conclusion: based on the results of the investigation the complaint is considered user error as the instructions for use specify the following in regards to pulling a stent back through the sheath: ¿do not withdraw the icast covered stent back into the bronchoscope or endotracheal tube once the device is fully introduced¿.Based on the details of the complaint and the investigation results atrium medical cannot find fault with the device in question.

• Brand Name: STENTS I-CAST
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8807963
• Report Number: 3011175548-2019-00777
• Device Sequence Number: 18918058
• Product Code: JCT
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 85453 - ICAST COVERED STENT 6MMX22MMX120CM
• Device Catalogue Number: 85453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/01/2019
• 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: OSCAR SHEATH; OSCAR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80