MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZIV6-125-14-6.0

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

After evar aaa procedures, the physician discover there was an angle from the distal end of endograft (common iliac) and the external iliac for this reason to decide to use our zilver stent to reduce the risk of kinking or stenosis.After the stent release they saw the discrepancy of distal marker and in the first time they supposed was a parallax effect, but after with a zoom they discover the stent appeared broken.They decide to do a fluoroscopy and when put the wire and after the pig catheter the stent go up at the level of visceral vessel.They tried to catch the stent with a balloon without success and with the risk to provate a endograft migration.A section of the device did remain inside the patient¿s body.The stent is inside the abdominal aorta at level of visceral vessel.It's not possible to retrieved the patient did require additional procedures due to this occurrence.Rx exposure to tried retrieve the stent without success.According to the initial reporter, the patient will experience adverse effects due to this occurrence.Probably in the future.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 08-dec-2023.

Manufacturer Narrative

Pma/510(k) # p050017/s002 and s003 device evaluation the ziv6-125-14-6.0 device of lot number c2071853 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records prior to distribution all zilver devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.An nc code (gen-111) was noted on the work order, however this unit was subsequently scrapped and would not have attributed to this complaint issue.Instructions for use/label it should be noted that the instructions for use (ifu0041) states the following: ¿the product is intended for use in the iliac arteries for the following treatments: - arteriosclerotic stenosis - total occlusions that have been recanalizated".There is evidence to suggest that the customer did not follow the instructions for use image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression 1.The complaint report states the zilver stent was used to reduce a kink or stenosis at the caudal margin of the evar device in the right common and external iliac artery.The zilver stent was deployed across this area of narrowing uneventfully and the complaint report states there was a discrepancy of the distal marker originally thought to be parallax.The initial image does have a slight off axis appearance to the caudal margin of the stent, nearly equal into the cranial margin of the stent, which is felt to be parallax, and within normal limits.However, the next image demonstrates significant change of the orientation of the caudal margin of the stent with a single radiopaque marker now being displaced caudally by approximately 1 cm.This caudal displacement was likely due to inadvertent catching of the caudal margin of the stent on the deployment device cone as it was retracted through the stent.There is no comment in the complaint report if while retracting the stent fluoroscopy was used to watch the removal of the device to ensure the deployment system did not engage with the stent.With the derangement of the caudal margin of the stent, this likely resulted in the stent lattice and radiopaque marker being slightly angled into the lumen of the vessel as opposed to flattened against the wall.Angioplasty across this area may have resolved this derangement and/or at least decreased the portion of the stent extending into the lumen of the vessel.2.After deployment and recognition of the caudal margin of the stent being abnormal, angioplasty was performed.There were no images with angioplasty balloon centered on the caudal margin of the stent.Post angioplasty images performed through the deployment sheath demonstrating an irregular appearance of the distal stent lattice suggesting either elongation or potential fracture of the stent while removing the deployment system.Unfortunately, while advancing the 5 french measuring pigtail catheter through the stent, the pigtail end of the catheter engaged with stent pushing the entire system centrally into the visceral abdominal aorta.Again, if fluoroscopic evaluation and close monitoring of the pigtail catheter while it was advanced through the stent was performed, this would not have occurred.It is a well-known complication that freshly placed stents can unfortunately migrate inadvertently while advancing devices through them and very close attention to this stent while advancing catheters and sheaths through the lumen should be performed at all times.In this case it does not appear that was the circumstance.3.The remaining images demonstrate significant distortion of the zilver stent due to what appears to be a significantly foreshortened configuration from causing the stent either invaginating or telescoping on itself while the catheter was advanced through it, likely inadvertently engaging with the caudal margin of the stent.This abnormally configured stent was left in the suprarenal aorta with final dsa image demonstrating flow through the stent, but not in a reasonable position to leave the stent.Initially attempts at removing the stent was using a balloon which was unsuccessful.There is no discussion of using a snare device which can be used to retrieve fresh intravascular stents and in all likelihood should've been used in this case instead of leaving the stent in the final configuration.Root cause review a definitive root cause of off label use was determined from the available information.It is known that the zilver stent was used to reduce the risk of kinking or stenosis.This is not in line with the intended use of the device.As previously mentioned, the ifu states the product is intended for use in the iliac arteries for the following treatments: - arteriosclerotic stenosis and total occlusions that have been recanalizated.This off label use, may have caused the discrepancy of the distal marker where the initial image showed a slight off axis appearance to the caudal margin of the stent.The slightly off axis stent, was further displaced when the claudal margin of the stent was inadvertently caught on the deployment device cone as it was retracted through the stent.This would have resulted in the stent lattice and radiopaque marker being slightly angled into the lumen of the vessel as opposed to flattened against the wall.This would have also caused the elongation or the potential fracture of the stent while removing the deployment system.As per the image review, a focal fracture cannot be confirmed from the images.When the user advanced the pig tail catheter through the stent, the pig tail end of the catheter, engaged with the angled stent and pushed the entire system in to the visceral abdominal aorta.It is unknown if fluoroscopy when removing the device or if fluoroscopic evaluation and close monitoring of the pigtail catheter while it was been advanced, was performed.Migration of freshly placed stents while advancing devices through them, is a well known complication.The zilver stent was used off-label.It was not supposed to be used to correct the angel/kink from the endograft evar (endovascular aneurysm repair).The stent was also not supposed to be deployed distally to a pre-existing stent.As per the imaging review, fluoroscopic evaluation and close monitoring were unlikely performed at all time.The stent migration was due to the retraction of the delivery system which engaged with the stent.The stent was retracted to the level of visceral vessel, it was a forced migration.During aaa endovascular aneurysm repair (evar) procedures, pigtail catheter use is very commonly used for angiography/imaging before, during, and after the procedure.It appears as though the advancement of the pigtail catheter, through the stent, advanced the ¿broken¿ piece of the stent into the proximal aorta, near the visceral vessels.Off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Confirmation of complaint complaint is confirmed based on visual and/or functional inspection.Summary according to the initial reporter, after evar aaa procedures, the physician discovered there was an angle from the distal end of endograft (common iliac) and the external iliac and for this reason decided to use a zilver stent to reduce the risk of kinking or stenosis.After the stent release they saw the discrepancy of distal marker and in the first time they supposed was a parallax effect, but after with a zoom they discovered that the stent appeared broken.They decide to do a fluoroscopy and after the pigtail catheter, the stent migrated up at the level of visceral vessel.They tried to catch the stent with a balloon without success and with the risk to provate a endograft migration.Confirmed quantity of 1 device, confirmed prior to use.According to the initial reporter, a section of the device did remain inside the patient¿s body.The stent is inside the abdominal aorta at level of visceral vessel.It's not possible to retrieved.The patient did require additional procedures due to this occurrence.Rx exposure to tried retrieve the stent without success.The patient will experience adverse effects due to this occurrence, probably in the future.Investigation findings conclude a definitive root cause of off label use was determined.The user has not complied with the requirements of the instructions for use with respect to the intended use of the device.Off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.As the device was used outside of their validated state and/or against the instructions provided in the ifu, it is not possible to predict how the devices will perform or function.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 17734568
• MDR Text Key: 323249071
• Report Number: 3001845648-2023-00693
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002375502
• UDI-Public: (01)10827002375502(17)260717(10)C2071853
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

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 Catalogue Number: ZIV6-125-14-6.0
• Device Lot Number: C2071853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male