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

Model Number 85441

Device Problems Loose or Intermittent Connection (1371); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician was able to cannulate the left renal artery with wire and sheath.Renal artery was 90% blocked with a heavy calcium burden and could not pass the balloon past lesion.When he removed the stent catheter the stent came loose from the balloon as it was pulled from the destino sheath valve.Physician tried to re-crimp stent on balloon with fingers, but it was still loose.

Event Description

The icast stent that would not cross the lesion was not implanted.The procedure was completed with another stent.

Manufacturer Narrative

The device in question was returned and evaluated to determine the cause of the complaint.Upon review of the returned 5mm x 22mm stent delivery system it was clear the stent had been dislodged as the stent was no longer positioned between the two gold radiopaque marker bands confirming the stent dislodgement.The stent was shifted distally off the balloon.It is obvious that the stent in this case was properly crimped during the manufacturing process.The balloon when the stent is properly crimped has defined stent witness lines in the balloon surface.Based on the witness lines on the returned product the stent was properly crimped.The details indicated that the lesion was creating a 90% obstruction of the renal artery.If this was the case it suggests that the diameter of the space going into the left renal artery was approximately 1mm in diameter as a 5mm stent was chosen for deployment.In this regard, the stent diameter in the crimped position would have been larger than the orifice created.This is also supported by the fact that the physician tried to pre-dilate the lesion with a balloon catheter but again was unable to pass the balloon catheter through the occlusion as well.The details that the physician provided stated that he shock waved the calcified plaque 3 times to create a path for the stent to track through to place the stent.The result was that stent still would not pass through the lesion so the icast was removed undeployed back through the steerable introducer sheath.The physician was eventually able to pre-dilate the lesion with a balloon catheter and then successfully able to deploy a different icast covered stent in the lesion being treated.Based on the details of the case there are two instances where there is a potential for the stent to become dislodged.The first is when the crimped stent was attempted to be pushed through the small opening in the lesion thus pushing the stent out of its original crimped position if too much force was applied in attempting to cross the lesion.The second instance is when the stent delivery system was withdrawn back through the steerable introducer sheath.It is possible that the proximal end of the stent caught the distal tip of the introducer sheath pushing the stent out of its original crimped position.The instructions for use specify the following: contraindications non-compliant obstructions where full expansion of a balloon dilatation catheter cannot be achieved during pre-dilation, or where obstructions cannot be dilated sufficiently to allow passage of the delivery catheter.Warnings do not use the icast covered stent in a non-compliant lesion where full expansion of the balloon dilatation catheter, appropriately sized for the lumen, cannot be obtained.Do not withdraw the icast covered stent back into the bronchoscope or endotracheal tube once the device is fully introduced.Precautions do not attempt to pull an unexpanded stent back through the bronchoscope or endo-tracheal tube since dislodgement of the stent may result (refer to removal of an unexpanded stent).Removal of an unexpanded stent should it become necessary to remove the icast covered stent from the lumen prior to deployment and a bronchoscope or endotracheal tube is being used, do not withdraw the icast covered stent back into the bronchoscope or endotracheal tube after the device is fully introduced.To remove the icast covered stent prior to deployment, the icast covered stent/balloon catheter should be withdrawn until the proximal end of the icast covered stent is aligned with the distal tip of the bronchoscope or endotracheal tube.The icast covered stent/balloon catheter, guidewire and bronchoscope or endotracheal tube, should then all be removed as one unit.After removal, the icast covered stent should not be reused.Caution do not attempt to pull an unexpanded icast covered stent back through the bronchoscope or endotracheal tube; dislodgement of the icast covered stent may occur.A review of the device history records was conducted.During the process of manufacturing a sampling of devices is performance tested to ensure the integrity of the product from every production lot of catheters produced.The sampling is based on an aql sampling based on product lot size.Typically, 20 samples are tested from every product lot.This lot of catheters passed all quality and performance criteria without any non-conformances.This includes the stent securement testing.The minimum stent retention specification is 2.9 newton¿s.The data as recorded in the device history record shows that the minimum stent dislodgement force was 8.2 newton¿s.Based on the details of the complaint, the inspection of the returned product and review of the device history records it cannot be confirmed that the icast covered stent was nonconforming.The root cause is most likely due to the patients vessel disease state making the delivery of the icast covered stent extremely difficult without pre-dilation or intervention of the lesion being treated.The details provided indicate after pre-dilation of the lesion a new icast covered stent was able to be successfully implanted.

Event Description

N/a.

• Brand Name: I-CAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10544504
• MDR Text Key: 208113751
• Report Number: 3011175548-2020-01146
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854411
• UDI-Public: 00650862854411
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: 85441
• Device Catalogue Number: 85441
• Device Lot Number: 425421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DESTINO 6.5F SHEATHSHOCK WAVE
• Patient Age: 82 YR