MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; PTFE COVERED STENT

Model Number 85355

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the stent did not move easily on the wire.

Manufacturer Narrative

Engineering investigation: the returned device was evaluated to determine the cause of the complaint (difficulty passing guidewire).Upon inspection the balloon was in the deployed state and in good condition.The catheter shaft was in good condition and showed no signs of damage.An 0.035in cordis emerald green guidewire was provided with the complaint.The guidewire was kinked slightly on the distal segment of the wire about 30cm from the j-tip.The guidewire lumen was flushed with water and the guidewire advanced into the catheter shaft.There was very little resistance initially but as the kinked section entered the catheter shaft the resistance increased.The guidewire was able to pass but not without moderate resistance.A new 0.035in cordis emerald green guidewire was obtained and advanced into the returned catheter shaft.The guidewire passed with very little to no resistance encountered.The wire passed thorough as expected.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 10 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.During the manufacturing of the v12 product there are two separate 100% guidewire lumen inspections conducted using a 0.035in guidewire to ensure the guidewire lumen is patent.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.The guidewire that was returned and used in the case had become damaged making it difficult to pass through the v12 stent delivery system.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.It may be difficult to advance a stent to the intended target for several reasons including, but not limited to, tortuous or calcified anatomy, incorrect sizing of the lesion or stent, or if there is deformity of the accessory devices such as a kink in a guide wire.The instructions for use (ifu) state potential adverse effects include, but are not limited to inadequate implantation or intimal trauma and it warns that only physicians trained in interventional techniques should use this device.The ifu also states do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.

• Brand Name: ADVANTA V12 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: 6847789
• MDR Text Key: 85626585
• Report Number: 3011175548-2017-00118
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/09/2018
• Device Model Number: 85355
• Device Catalogue Number: 85355
• Device Lot Number: 232115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• 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?: Yes
• Date Device Manufactured: 12/09/2015
• 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 Age: 86 YR