MAUDE Adverse Event Report: ATRIUM MEDICAL ICAST COVERED STENT; PROSTHESIS, TRACHEAL

Model Number 85424

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation, a follow up report will be submitted.

Event Description

Atrium icast was used during a fevar (fenestrated endovascular aortic repair).This particular icast was being used to stent the sma (superior mesenteric artery).After being prepped without negative prep, the icast was placed over a rosen guidewire.035" thru a cook ansel 1 7fr 55 cm length introduction sheath.The stent was placed in the sma covered by the sheath.It was not deployed yet.The doctor then decided he needed to perform another angiography of the sma thru the sheath.He removed the icast delivery catheter from the sheath.On replacing the icast onto the wire to reinsert it, the doctor noticed the stent had become loosened from the balloon and he was able to slide the stent back and forth on the balloon past the radiopaque markers.It was then decided that it was no longer safe for use and removed from the wire.

Manufacturer Narrative

Analysis: the details provided indicate that the stent was placed in the superior mesenteric artery (sma) covered by the sheath.It was not yet deployed.The clinician then decided he needed to perform another angiography of the sma thru the sheath.He removed the icast delivery catheter from the sheath.The instructions for use (ifu) specify the following: ¿do not withdraw the icast covered stent back into the bronchoscope or endotracheal tube once the device is fully introduced¿.In this case a 7fr introducer sheath.Upon removing the returned device from the packaging it was noticed that the stent was loose on the balloon.The stent had a slight curvature to it and was in good condition.The crimped stent diameter was measured and was 2.4mm.This diameter is indicative of a stent that was properly crimped in manufacturing.On close inspection the proximal balloon bond was noted to be necked down to a smaller diameter.The bond diameter was approximately 0.030in.This diameter is approximately 0.030 smaller than a normal balloon bond that has not been damaged.Typically a neck down of the shaft is caused by the physician forcibly removing the device back through the introducer sheath.This also may explain why the stent was dislodged.The surface of the balloon was evaluated to determine if the stent was crimped properly during manufacturing.When the stent is crimped onto 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.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 (7fr).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.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.The minimum stent retention data point was 9.6 newtons.All 10mm stents must meet a minimum stent securement value of 5.5 newtons.The data from this lot of catheters indicates that the value was almost double the required value.Conclusion: based on the passing results of the quality and performance testing atrium medical cannot determine the cause of the stent being dislodged.It is possible it was loosened by withdrawing the catheter back through the introducer sheath after initially reaching the target site.

• Brand Name: ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7235020
• MDR Text Key: 98837443
• Report Number: 3011175548-2018-00089
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2020
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 423900
• Other Device ID Number: 00650862854244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR