MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT; PTFE COVERED STENT

Model Number	85419
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/15/2017
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
It was reported that the stent was delivered to the left iliac artery but was deemed to be too long.When the physician attempted to remove the stent it came off the balloon and remained in the left iliac artery resulting in the physician placing another device to secure it in the artery.
Additional Manufacturer Narrative
Engineering investigation: the details provided indicate that the stent came off the balloon upon withdrawing the stent back out of the patient because the stent was deemed to be too long.Without the actual device in question we cannot confirm the complaint.The instructions for use specify the following in regards to removing the device: do not attempt to pull an unexpanded stent back through the bronchoscope or endo-tracheal tube since dislodgement of the stent may result.Based on the details of the complaint the device was attempted to be pulled back out through the introducer sheath in this case.A full review of the catheter lot history records for the devices in question was performed.The records indicate that this lot of catheters passed atriums final lot qualification testing.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.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).Result: all quality inspection samples passed this final inspection without any non-conformance's noted during the final lot qualification testing associated with the complaint.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.Result: all quality inspection samples passed this final inspection without any non-conformance's noted during the final lot qualification testing.Conclusion: based on the passing results of the device history records, atrium medical can find no fault with the device in question.It is possible that the stent was pushed off the balloon by making contact with the distal end of the introducer sheath upon withdrawal of the device.Clinical evaluation: the iliac arteries are the branches that the aorta divides into around the level of the belly button to provide blood to the legs and the organs in the pelvis.This blockage is typically caused by a buildup of plaque and/or calcification within the walls of the blood vessels.Angioplasty is a procedure to open narrowed or blocked arteries.Angioplasty and stent placement are two ways to open blocked peripheral arteries.A stent can become dislodged if the vessel has calcification or severe disease, if the vessel has not been properly pre-dilated, if the stent or sheath has not been sized correctly or if the physician uses force to advance or withdraw the catheter.The instructions for use (ifu) instructs do not attempt to pull an unexpanded stent back through the delivery device since dislodgement of the stent may result.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• MDR Report Key: 6894792
• Report Number: 3011175548-2017-00139
• Device Sequence Number: 810028
• Product Code: JCT
• UDI-Device Identifier: 00650862854190
• UDI-Public: 00650862854190
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: 85419
• Device Catalogue Number: 85419
• Device Lot Number: 226982039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 10/10/2017
• 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