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

Model Number 85444

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The procedure was a percutaneous 4 vessel fenestrated endovascular aortic aneurysm repair.The stent came off the balloon after insertion into patient.Stent and balloon both were retrieved successfully and returned to the sterile field.

Manufacturer Narrative

Medwatch received: (b)(4).

Event Description

Medwatch received: (b)(4).

Manufacturer Narrative

Engineering investigation: the returned device was evaluated to determine the cause of the complaint.Upon inspection the stent was no longer on the balloon and had been flattened.The balloon was still in the folded position and showed no signs of positive pressure.The balloon surface was evaluated to determine if the stent was crimped properly during manufacturing.When a stent is crimped on to the folded balloon the stent frame leaves impressions of the stent frame on the surface of the balloon.The impressions indicate if the stent was properly crimped on to 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 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-conformances noted during the final lot qualification testing associated with the complaint.There were no issues in regards to the stents being able to pass through the introducer sheath.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-conformances noted during the final lot qualification testing.The in-process test data shows that the minimum stent dislodgement force was over 8.5 newtons (n).This is well over the minimum requirement of 5.5n.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of stent delivery systems in question.Clinical evaluation: endovascular aortic aneurysm repair (evar) is a minimally invasive procedure that is used to treat an abdominal aortic aneurysm.The procedure includes placement of a large endograft within the aorta and stent placement into the adjacent arteries as protection from occlusion by the graft.The graft is then secured via fixation barbs to prevent migration.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.A stent may migrate due to inadequate implantation at the target site.If a stent migrates it may result in the need for surgical or interventional revision to prevent thrombus formation, ischemia, vascular occlusion and pain.The instructions for use (ifu) warn that inadvertent, partial, or failed deployment or migration of the device may require surgical intervention.The ifu also notes that complications and adverse events can occur when using any endoluminal device.These include, but are not limited to: misplacement, migration, infection, septic shock, occlusion, perforation or hemorrhage.

• Brand Name: ICAST COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 6861003
• MDR Text Key: 85908378
• Report Number: 3011175548-2017-00121
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854442
• UDI-Public: 00650862854442
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2017

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
• Device Operator: Physician
• Device Expiration Date: 03/22/2020
• Device Model Number: 85444
• Device Catalogue Number: 85444
• Device Lot Number: 249080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 09/29/2017; 10/17/2017
• Supplement Dates FDA Received: 10/02/2017; 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• 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: 69 YR
• Patient Weight: 79