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

Model Number 85452

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.Not available for return.

Event Description

The doctor had already deployed the stent successfully, but it was not long enough.He used another stent to extend the treatment site, and he expanded the balloon to the rated burst pressure of 12 atm; at this point the balloon ruptured.The stent was deployed appropriately and the physician removed the device contained within the sheath out of the patient with no immediate impact to the patient.

Manufacturer Narrative

Analysis: the device in question was not returned for evaluation.The complaint details indicate that the device had ruptured upon reaching the rated burst pressure of the product of 12atm.It is not known how the balloon ruptured during the procedure.The case details provided indicate the following: ¿the icast covered stent was used in a fenestrated endovascular aortic repair (fevar) with a custom made device from cook.The icast was used in both renal arteries; the product with the ruptured balloon was used in the left renal artery.The device was advanced from the brachial artery down the aorta through the cook endoprosthesis.It was then inserted into the left renal artery, through another icast (6x22x120).The first stent was placed in the ostium (proximal) of the left renal artery, and through the fenestration of the cook device.Approximately 4 cm of the first icast stent extended into the aorta and was flared with an abbott armada balloon to oppose against the aortic wall.The device in question was delivered through the first stent and placed distally to the ostium.It was expanded to rated burst pressure (12 atm) when the balloon ruptured.¿ the cook incorporated endoprosthesis has been known to have fixation barbs that are laser sharpened to anchor the endograft in the aortic wall to keep the endograft from migrating.There is a possibility that the icast covered stent made contact with one of the multiple fixation barbs.As the approach for delivery was from the brachial artery the icast covered stent would have had navigate through the endograft.A review of the device history records indicates that this lot of icast covered stents passed all performance and quality requirements.Below is a list of the quality and performance criteria that every lot of v12 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 details there is a possibility that the balloon was scratched by one or more of the fixation barbs of the cook endograft used in the case.As the device in question was not returned and the device history records indicate that this lot of icast covered stents passed all quality and performance requirements, atrium medical corporation cannot conclude that the device was faulty.H3 other text : not returned.

Event Description

N/a.

• Brand Name: ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8993857
• MDR Text Key: 159987206
• Report Number: 3011175548-2019-00958
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854527
• UDI-Public: 00650862854527
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85452
• Device Catalogue Number: 85452
• Device Lot Number: 441026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK FENESTRATED ENDOPROSTHESIS
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR