MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS ADVANTA V12; STENT, ILIAC

Model Number 85355

Device Problem Premature Separation (4045)

Patient Problems Ischemia (1942); Multiple Organ Failure (3261); Insufficient Information (4580)

Event Date 03/19/2023

Event Type  Death  

Event Description

Balloon that does not deflate, the sheath ends up breaking on removal, need to open the superior mesenteric artery for removal of the balloon.Current condition of the patient: opening of the superior mesenteric artery.

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Manufacturer Narrative

Additional information: sections b5, b7, d10 & h6.Corrected information: section h6 - health effect - clinical code.

Event Description

During equivalent of roms / stenting of the proximal anasomotosis of point thoraco ams procedure the balloon did not deflate.The sheath ends up breaking on removal, need to open the superior mesenteric artery for removal of the balloon.Patient intervention needed when opening of the superior mesenteric artery.Getinge was informed on (b)(6) 2023 that current status of patient is deceased.Per the physician, patient died some days after from mesenteric ischemia and associated multiple organ failure, not from procedure and without consequence of device malfunction.

Event Description

During emergent modified roms (retrograde open mesenteric stenting), thrombectomy, angioplasty, and stenting, the advanta v12 balloon did not deflate.The catheter shaft broke on removal, approximately 1-2mm proximal to balloon.An incision was made in the superior mesenteric artery bypass graft for removal of the balloon, and then successfully closed.Getinge was informed on 31-mar-2023 that current status of patient is deceased.Per the physician, the patient underwent small bowel resection and subtotal colectomy at the time of the (b)(6) procedure.Patient expired (b)(6) 2023 from mesenteric ischemia and associated multiple organ failure, not from procedure and without consequence of device malfunction.

Manufacturer Narrative

Additional information: sections b5.Corrected information: sections b3, b7.

Manufacturer Narrative

The claim was that the balloon did not deflate causing the balloon to separate from the catheter shaft upon removal.The balloon was then required to be surgically removed.The portion of the balloon catheter, containing the separated balloon and underlying catheter shaft, was returned to the manufacturer and evaluated.The distal weld of the balloon to the catheter shaft was fully intact and in good condition.The balloon had separated from the shaft at the proximal weld area due to the force imparted during attempted removal.A visual inspection of the balloon was conducted under magnification and showed no evidence that the balloon contained a hole or leak at the time of the procedure.Patency of the skive holes under the balloon, which provide a fluid path for the inflation media to enter and be removed from the balloon, was confirmed.The device history records review did not identify any non-conformances.All product quality and performance requirements were met.There was no on demand maintenance of associated manufacturing or test equipment identified around the time of manufacture and all equipment was in calibration.No significant design, material, procedural or process changes around the time of device manufacture have been identified.An important comment made by the physician was that due to the emergent conditions and alternate staff assisting in the procedure, he ¿could not guarantee that the contrast solution was diluted with saline.¿ the balloon was returned with a small amount of fluid from the procedure still inside.This fluid was analyzed using fourier transform infrared spectroscopy (ftir) and energy dispersive spectroscopy (eds).The analysis confirmed the suspicion that the inflation media was contrast with no dilution.The tested fluid from the returned balloon showed the same chemical make-up as the control substance, undiluted contrast agent i.E.Visipaque¿ (iodixanol injection).There was no presence of chlorine in the sample, which would be expected to be present had the contrast been diluted with saline.Given the use of undiluted contrast, the deflation time of the balloon would be significantly increased and deflation would be more difficult compared to diluted contrast, as the viscosity is much greater.The withdrawal technique utilized in the case was described as an ¿intro climbing maneuver on the balloon at the moment of deflation¿.This technique requires the user to pull a vacuum on the balloon using the recommended 20cc syringe while simultaneously advancing the introducer sheath over the balloon while deflating.This technique does not allow for the balloon to fully deflate or for visualization that the balloon is fully deflated under fluoroscopy prior to withdrawal, as recommended in the advanta v12 instructions for use.Allowing sufficient time for full deflation of the balloon and visual verification that the balloon is fully deflated prior to withdrawal via fluoroscopy are important steps to minimize resistance during withdrawal and the resulting potential for separation of the balloon or catheter hub from the delivery catheter.It is also important to note that the advanta v12 has not been tested or evaluated for use with or in conjunction with vascular grafts or for stenting anastomosis locations such as in this procedure where a graft was attached to an artery such as the aorta in this case.The complaint history and capa searches identified several related complaints and two related capas for component separation (capa 429004 and 789082).The complaint issue is adequately covered in the risk management file, is operating within the approved risk profile.No evidence that a manufacturing defect caused or contributed to the reported failure was discovered during the investigation.Component separation during procedure has been previously investigated under capa 429004.The most significant factor contributing to component separation is fluid remaining in the balloon during removal due to insufficient deflation of the balloon prior to withdrawal (e.G.Due to insufficient time allowed for deflation, inability to deflate due to device damage/defect).The excessive force applied to the delivery system in attempt to remove the device can cause the catheter shaft to break, causing the balloon and/or hub to separate from the rest of the delivery system.The findings of this complaint are in alignment with the above findings such that the ¿intro climbing maneuver¿ also known as ¿swallowing technique¿ described in the complaint does not time the deflation of the balloon.Additional contributing factors include the off-label use of the device to stent the anastomosis of a vascular by-pass graft to the superior mesenteric artery and the fact that the contrast media had not be diluted (increasing the overall time requirement for full deflation to be acheived).Therefore, the root causes assigned to this complaint include operational context and user error.

• Brand Name: STENTS ADVANTA V12
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 16649196
• MDR Text Key: 312402826
• Report Number: 3011175548-2023-00088
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85355
• Device Catalogue Number: 85355
• Device Lot Number: 485832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTRODUCER SHEATH - BOSTON 7*25CM, TERUMO 0.035 GW.; UNKNOWN..
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 60 KG