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

Model Number 85364

Device Problem Difficult to Remove (1528)

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

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Report received stated that during the deflation of the balloon, they deflated partially, the doctor kept sucking the balloon for more than 5 minutes to deflate them but nothing changed, there was still some contrast and air inside the balloon which forced the doctor to pull the balloon with risk of major complications.

Event Description

N/a.

Manufacturer Narrative

The devices were not returned for evaluation.A review of the images received was conducted.The first image shows that the left iliac artery was badly stenosed and the right iliac did not appear to be diseased at all.The additional images show the two stents opening properly as the "dog-bone" shape is easily seen as the stents open.This is normal.The stent begins to open prior to reaching the nominal inflation pressure of 8atm.The image does not show the pressure gauge used in the images so it cannot be determined at what pressures the images were taken.The stents are then shown fully opened.The stent in the right iliac is fully opened and there is a slight narrowing in the center of the stent in the left iliac due to the stenosis that was seen in this area as the vessel was much smaller in this location due to the disease.One of the images shows the balloons fully deflated as they are being withdrawn out of the deployed stents.Within the multiple images of the devices, there is no indication that the stents did not open fully or that the balloons were not fully deflated.The claim was that the stents did not open fully at the nominal pressure of 8atm as specified on the product label.When asked about how the stents reached their full diameter the information provided stated that the stents were brought to the rated burst pressure of 12atm also described on the product label.Based on the images it is not clear that the stents did not open fully at nominal pressure and the balloons within the images do not show that there is contrast still within the balloon.Within the instructions for use (ifu) the following is stated: deployment - deflate the balloon by pulling vacuum on the inflation device to its maximum volume for 40 seconds.Verify full balloon deflation via fluoroscopy before proceeding.The information provided stated that the balloons were deflated only partially after multiple attempts were made to deflate the balloons and that there was still air and contrast in the balloon after waiting for five minutes.The images provided show that the balloons were fully deflated and were viewed as being withdrawn out of the fully deployed stents.A review of the device history record data found that all 20 samples tested were brought to nominal inflation pressure of 8 atm and the stent dimensions measured for reference.All 20 samples deployed properly and without issue.The balloon was then deflated on all 20 samples and the stent measured again but with no pressure from the balloon.This is described as "recoiled" stent diameter.All 20 samples measured passed the recoiled stent diameter specifications requirements.Recoil is defined as the difference between the diameter at nominal pressure and the diameter following deflation from nominal pressure.The recoiled stent diameter requirements are specified in the part specification drawing.For the finished good code 85364 for the advanta v12 10mm x 38mm x 120cm product the recoil specification is 10mm +1.0mm/ - 0.8mm or 11.0mm to 9.2mm.The smallest diameter recorded of 20 samples was 9.94mm.Based on the images provided it appears that the balloons were fully deflated and viewed as being withdrawn out of the fully deployed stents.Without the return of the devices for evaluation, the reported complaint cannot be confirmed.H3 other text: not available for return.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• 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: 11766192
• MDR Text Key: 250185795
• Report Number: 3011175548-2021-00475
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/30/2021

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 Expiration Date: 10/01/2021
• Device Model Number: 85364
• Device Catalogue Number: 85364
• Device Lot Number: 436831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/27/2021; 11/09/2021
• Supplement Dates FDA Received: 06/03/2021; 11/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 68 KG