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

Model Number 85365

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a femoral cross over procedure, advanta v12 stent was to be put through a teromo 7f, 45cm, destination introducer.There was a lot of resistance and trouble getting the stent through.The problem was solved by using other products.

Manufacturer Narrative

Investigation summary: the details of the complaint are the following: ¿during a femoral cross over procedure, advanta v12, lot 49684062 was to be put through a teromo 7f, 45cm, destination introducer.There was a lot of resistance and trouble getting the stent through.¿ additional important details for consideration were provided in the answers to the gfe questions: advanta v12 was placed in the middle/ last third part of a tortuous aa iliaca communis sinister.Because of the resistance when pushing the stent forward they created a rift in the iliac communis.Gore viabhan vbx stents were placed through the same 7fr introducer sheath to resolve the rift, without reported issue.Note: gore viabahn 10mm stents are labeled as 8fr compatible.The physician felt resistance passing through the valve and through the entire length of the sheath.He noted that there was no difference in resistance felt at the valve versus the remaining length of the sheath.There was no resistance advancing over the guidewire prior to insertion into the sheath.The physician confirms all ifu steps were following including wetting the stent with saline prior to insertion, flushing the sheath with saline prior to use, and inspection of the catheter/sheath for kinks or defects prior to the procedure.The physician is very experienced with the advanta v12 product and regularly uses the terumo destination sheath with the v12 product without issue.In summary, the 10mm x 59mm x120cm advanta v12 had a difficult time passing through the introducer sheath but was ultimately able to pass through the sheath.The advanta v12 stent was ultimately deployed and placed, but due to creating a rift in the iliac communis while trying to push the stent forward, additional stents had to be placed.The advanta v12 product and the terumo destination introducer sheath used in the case were not returned, as they were discarded by the hospital.Angiographic images of the patient¿s anatomy where the stenting was performed were provided by the physician.The review of the images received indicate as stated in the case details that the iliac artery was tortuous creating a degree of difficulty when tracking the advanta v12 to the intended target.The intended target was the left iliac artery that was approached contralaterally over the iliac arch from the right femoral artery as seen in the imaging provided.There would be an expected amount of resistance when tracking over the iliac arch as seen in the images provided as this bend over the iliac arch is at a rather acute angle.Bi-iliac stenting of the right and left iliac was performed using two gore vbx stents to repair the rift in the iliac communis.The vbx stents placed in the left iliac and into the distal aorta had been placed through a sheath that had been placed in the left femoral artery and through the previously placed advanta v12 covered stent.It is important to note that the gore vbx stents are intended to be placed through 8fr introducer sheaths.The details from the complaint state that the 7fr sheath used to deliver the advanta v12 had not been removed; thus the gore stents were able to successfully track through a smaller introducer sheath without 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 7fr cordis brite tip introducer sheath.Also as part of lot qualification testing, the diameter of the crimped stent delivery system is measured prior to deployment using a laser micrometer.This measurement is taken for reference only.For the 20 samples measured, the average crimped stent od was 2.50mm, and maximum od measured was 2.57mm.Analysis of the data does indicate the possibility of some samples being larger than the inner diameter of the terumo destination 7fr introducer sheath, which per the terumo website and product documentation, is 2.57mm.However, the data for this lot is in line with historical production values.Therefore, also given the overall low rate of complaints related to this failure mode, the dimensional analysis of the lot alone is not conclusive.To determine if crimped stent diameter substantially larger than the sheath id can compromise the ability of the delivery system to pass through a 7fr terumo destination sheath, test samples were purposely manufactured with crimped stent od in line with the average crimped stent od observed in the complaint lot, as well as samples with an od targeted at or above the sheath id.Nine samples with an od ranging from 2.50mm to 2.75mm were passed through a 7fr, 45 cm terumo destination sheath, catalog number rsr05, lot number xd20 (cross-cut valve, hockey stick curve style).All samples were able to successfully pass through the sheath.This testing supports that the dimensions of the stent delivery system alone are likely not the cause of the complaint.A prior capa identified that there is variability in introducer sheath design and no guidance, standards or regulations for french sizing, which are provided in integers (6 french, 7 french, 8 french, etc.), allowing for variability in actual size when labeled as 7 french.As the allowable tolerances of the terumo destination sheath and the exact inner dimensions of the sheath used in the case are unknown, it is possible that such variability could be a contributing factor to the complaint, particularly if the inner diameter of the sheath used in the complaint case happened to be smaller than the labeled 2.57mm.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 review of non-conformances going back two years indicates that there has been no related ncr¿s associated with the complaint.The complaint history shows that there has been 7 other complaints related to difficulties delivering the stent while tracking to the target area.None of the devices in question were returned and thus none of the complaints were confirmed.Only one of the 7 complaints listed involved the same size device as this complaint (10mm x 59mm device).Four of the 7 complaints were used in off-label procedures (e.G.Celiac artery, superior mesenteric artery, iliac side branch (z-bis)), where it was noted or presumed that the difficult/tortuous anatomy was a likely a factor in the difficulty passing the stent through the sheath and/or the stent dislodgement.Limited or no details were provided in the three remaining cases in order to determine possible cause.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 in regards to inspection of the device prior to use, for selection and use of accessory devices for the intended use, as well as to not force passage or removal of the device.Without evaluating the specific advanta v12 device and terumo sheath in question, the complaint cannot be confirmed, and makes it difficult to establish a cause.Based on the information available, the following elements could be, but are not the only, possible causes: based on the data contained within the dhr, it is possible that the dimensions of the stent delivery system, combined with variability in the introducer sheath inner diameter have resulted in an interference fit.It must also be considered that the device was used in a very complex case, and that the tortuosity of the vessel and the patient¿s anatomy could have certainly contributed to the resistance felt ultimately, the root cause is undeterminable.Device discarded by hospital.

• 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: 17347714
• MDR Text Key: 319486905
• Report Number: 3011175548-2023-00153
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85365
• Device Catalogue Number: 85365
• Device Lot Number: 496843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TEROMO 7F, 45CM, DESTINATION INTRODUCER,VBX STENTS
• Patient Age: 77 YR
• Patient Sex: Female