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

Model Number	85424
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2019
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 procedure was kissing iliac stents.The target was the left iliac artery.The vasculature disease state was ischemic gangrene of the left lower extremity.The target had a very high-grade stenosis of the proximal left common iliac artery.The sheath was a 6f x 11cm sheath.After deployment of the stent with only one inflation, the balloon burst at 10 atm and when attempting to remove the balloon, it disengaged from the shaft.It had to be removed with the entire system.No post operative issues.
Additional Manufacturer Narrative
Analysis: the icast covered stent delivery system was not returned.Because the device was not returned it is difficult to determine if there was any issue with the manufacture of the device.A review of the device history records indicates that this production lot of catheters passed all quality and performance criteria as listed below.The complaint indicates that a balloon rupture occurred.The review of the device history records shows that the minimum burst value seen during the product performance testing of 20 complete catheters was 19.6 atmospheres.This is well above the rated burst pressure of 12 atm as specified on the product label.All the balloons during the balloon burst testing failed with a longitudinal tear.During the process of forming the balloon of the catheter 29 additional samples were balloon burst tested.The lowest value seen from these samples was 19.1 atm.This is also well above the 12 atm requirement.The details provided indicate that the stent ruptured during a kissing stent procedure that had a very high grade stenosis.The details provided do not indicate if the area to be stented had been pre-dilated prior to performing the kissing stent procedure.It is possible that the area was highly calcified and the balloon ruptured on the calcification, but this cannot be confirmed.The details provided also state that ¿the balloon disengaged from the shaft upon removal¿.Because the balloon had a hole in it, the balloon would have not been able to be deflated.Any remaining fluid in the balloon would have made withdrawal back through the sheath difficult.The balloon during manufacture of the device is thermally welded to the catheter shaft.During the manufacture of the device 20 catheters from every lot produced have the proximal balloon bond tested to ensure the bond strength meets specification.The specification is that the balloon bond must not separate under 15 newton¿s (n).The tensile force data from the 20 units tested from this production lot shows that the lowest tensile force value was 24 n¿s.The average break force was 26.7 n¿s.This is well above the 15 newton requirements.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/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 investigation atrium medical corporation cannot conclude that the device was defective.It is possible that the balloon was damaged at some point during the procedure, possibly from calcifications as the details indicate the target had a very high-grade stenosis.
Event or Problem Description
N/a.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8582451
• Report Number: 3011175548-2019-00512
• Device Sequence Number: 2192231
• Product Code: JCT
• UDI-Device Identifier: 00650862854244
• UDI-Public: 00650862854244
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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 Expiration Date: 01/02/2022
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 441017
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR