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

Model Number 85443

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Stent came loose on balloon catheter during preparation before introduced to patient.

Event Description

N/a.

Manufacturer Narrative

Analysis: the returned device was examined and it was noticed that the stent was dislodged on the balloon.The stent delivery system was soiled from bodily fluids.The stent had a slight curve to it.The catheter shaft was also stained with blood.The crimped stent diameter was measured and was 2.1mm.When a stent is crimped it leaves impressions of the stent frame on the surface of the balloon.The impressions are very evident.The balloon was in good condition with no signs of damage.The catheter shaft was also in good condition with no signs of damage.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); stent retention testing.The stent must not dislodge from the balloon after crimping at a value below 5.5 newtons (n) for a 7fr or 6fr compatible device.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.The device history records also indicate that the lowest stent retention value seen during testing was 8.2 n.The requirement is that the stent must not dislodge from the balloon below 5.5 n.The details provided indicate that the stent was loose when the device was prepped by the clinician.The manufacturing requirement for inspection prior to packaging is to ensure that the stent is firmly crimped to the balloon.This inspection is conducted on 100% of the product produced.If a stent was found to be loose on the balloon, the sample would have been scrapped.A stent that has not been crimped looks drastically different than a stent that has been crimped.Based on the inspection of the returned catheter and the device history records review atrium medical cannot conclude that the stent was loose upon removal from the packaging tray.Other potential causes may also be considered but cannot be verified via a post return examination.In many cases dislodgement has been found to occur due to improper prepping of the device, specifically applying positive inflation pressure to the balloon which can loosen the grip between the stent and the balloon.Another potential cause for stent dislodgement has been when operators grasp and tug on the stent to verify stent retention.This technique can dislodge the stent if too much force is applied.In some cases we have also learned that operators mistake the white eptfe covering on the stent for a removable sheath and try to pull it off.We recognize that this institution¿s personal have used the product many times and as such these causes may not apply to them, however we have not been able to determine any fault due to manufacturing.Conclusion: based on the investigation atrium medical corporation cannot conclude that the stent was loose upon removing the device from the package.

• 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: 8889369
• MDR Text Key: 154423122
• Report Number: 3011175548-2019-00868
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854435
• UDI-Public: 00650862854435
• 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
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2022
• Device Model Number: 85443
• Device Catalogue Number: 85443
• Device Lot Number: 443681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 65