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

Model Number 85353

Device Problems Failure to Advance (2524); No Apparent Adverse Event (3189)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Distributor stated: i have been informed by procurement that stent was "explanted".Informed by nurse that it was removed due to not being able to cross calcium at lesion.

Event Description

Additional information receive stated: the operational procedure was aortogram of the superior mesenteric artery and aorta and attempt at treatment of the superior mesenteric artery branch aneurysm.The operating clinician was contacted through his office staff.His reply when he was asked what the issue with the stent was - he said the stent wouldn't track to cover the origin of visceral aneurysm.Resistance was felt causing the sheath to be pushed out of the sma.Subsequent attempts to exchange wires resulted in the dislodgment of a key wire needed for stent placement.Angiographic runs revealed some spasm in the superior mesenteric artery and a potential small dissection.Procedure was terminated, and the patient was closely monitored postoperatively.Ultrasound scan the next day indicated good flow in the superior mesenteric artery.Future intervention planned.

Event Description

N/a.

Manufacturer Narrative

Additional information: section h6 investigation summary: the details provided indicate that the advanta v12 stent graft was not able to be placed across the neck of a visceral aneurysm.The graft was withdrawn and the case completed without any further intervention due to the presence of a superior mesenteric artery spasm and small dissection.The original details mention that ¿the device was removed due to not being able to cross calcium at the lesion.¿ the procedure as an aortogram of the superior mesenteric artery and aorta and attempt at treatment of a superior mesenteric artery branch aneurysm.The operation report was provided.The report reads as follows: ¿a right common femoral puncture was performed using ultrasound guidance and colour flow doppler confirmation and a 6 f sheath inserted.Access was gained to the superior mesenteric artery after performing an aortogram which shows the celiac artery to be occluded.The superior mesenteric artery was defined with selective angiography and there is a closed branch to the origin of the superior mesenteric artery that feeds into the aneurysm and this was accessed and crossed.The neck of the aneurysm is wide and so coil embolization may be difficult to keep the coils in place.A decision was made to try to cross the neck of the aneurysm and deliver a covered stent graft.With everything in position initially the stent graft appeared to be making its way gently into position but then suddenly the resistance caused the sheath to be pushed back out of the superior mesenteric artery and so the delivery system was withdrawn which allowed the sheath to fall back into place.Further attempts to exchange wires were undertaken but during these attempts one of the wires was dislodged that was key to getting the stent into place and angiographic runs showed that there was some spasm in the superior mesenteric artery now and possibly a small dissection.Flow looked good and on the basis of safety the procedure was terminated, and the patient was followed closely postoperatively, and an ultrasound scan the next day shows the superior mesenteric artery to be flowing nicely.¿ the complaint can be confirmed based on receipt of the formal operative report.However, based on the details provided there is no assertion of a device malfunction or deficiency and no evidence to conclude that the device was faulty or manufactured improperly.The details provided within the operative report indicate the lesion they were treating was calcified at the location of the superior mesenteric artery and the stent was to be used to cover an aneurysm.At some point during the procedure the vessel spasmed, but it is unknown if this contributed to the inability to pass or is the result of the attempt to pass the stent.It is also not known if the claimed dissection occurred prior to the advancement of the advanta v12 catheter of from the introducer sheath and or one of the guide wires used in the case.Further, the advanta v12 was used in a non-indicated anatomy.The device is indicated for restoring and improving the patency of the iliac and renal arteries.The advanta v12 has not been tested or evaluated for use in the superior mesenteric artery for aneurysmal exclusion.In this regard the most likely root cause for the stent not passing through the lesion is the operation context of the procedure.The subject device was not returned.A contemporaneous device sample was not requested as the conditions experienced during the clinical procedure would not be able to be duplicated and there is no evidence that manufacturing contributed to the issue.A review of the device history records was conducted.As part of lot acceptance, an aql 1.0 sampling of the lot is performance tested to confirm the ability of the delivery system to pass through the labeled introducer sheath size provided on the product label without damage to the catheter or dislodgement of the crimped stent.The 20 samples tested for the lot in question met this requirement using a 6fr cordis brite tip introducer sheath.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.The complaint history shows that there have been 6 other complaints related to difficulties delivering the stent while tracking to the target area.All were part of procedures related with aortic endografts where the target was the celiac artery (off-label).A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.The instructions for use provide adequate instruction, clear indications for use, and contraindicate the use of the device within calcified lesions h3 other text : device not available for return.

• 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: 18712740
• MDR Text Key: 335481248
• Report Number: 3011175548-2024-00062
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 85353
• Device Catalogue Number: 85353
• Device Lot Number: 501271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/05/2024; 04/16/2024
• Supplement Dates FDA Received: 03/01/2024; 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6F SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female