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

Model Number 85414

Device Problem Break (1069)

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

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician delivered the stent to the target and determined it was too long.He removed the stent successfully and commented that the hub was damaged.

Manufacturer Narrative

Correction: this mdr was originally submitted on october 10, 2017 the mdr submission had an error in the mdr number (b)(4) the mdr number should have been 3011175548-2017-000122.This mdr is being submitted to correct the mdr number and provide the follow-up additional information.Engineering investigation: the details provided indicate that the inflation manifold was damaged during withdrawal of the un-deployed stent back through the introducer sheath.Without the actual device in question we cannot confirm the complaint.The manifold of the device is made from a very strong polycarbonate.The manifold is connected to no less than three separate pieces of equipment that is threaded on to the luer fittings of the manifold.A series of questions have been sent to obtain more detail concern the damage to the manifold they were as follows: · was the damage to the hub noticed before or after removing the device? · did the hub become disconnected from the delivery catheter? · was the damage due to a connection issue with the stopcock? answers to these questions would have clarified the issue the physician claimed to have had during the procedure regarding the damage to the manifold.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.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.The instructions for use (ifu) warn that special care should be taken to ensure that the appropriate size device and guidewire are selected prior to introduction.Native lumen dimensions must be accurately measured, not estimated and do not withdraw the stent back into the delivery device once it has been fully introduced.The ifu directs to achieve accurate measurement and ensure precise sizing and placement of the device, use image-centered, magnified-view fluoroscopy, including a marker guide wire or catheter.Check that the diameter and length of the device as well as the balloon catheter length are correct before removing the packaging.

• Brand Name: ICAST COVERED STENT
• Type of Device: PTFE COVERED STETN
• 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, 03054
• MDR Report Key: 6859310
• MDR Text Key: 85825096
• Report Number: 3011175548-2017-00122
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854145
• UDI-Public: 00650862854145
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/20/2020
• Device Model Number: 85414
• Device Catalogue Number: 85414
• Device Lot Number: 415636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2017
• 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
• Treatment: AMPLATZ 0.035 GUIDE WIRE; APTUS TOURGUIDE 7F X 75 INTRODUCER SHEATH; COOK TX2 ENDOGRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR