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

Model Number 85364

Device Problem Deflation Problem (1149)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

It was reported: "during the placement of a stent in the iliac artery, the balloon of the stent deflates with great difficulty: passage through the introducer in force." no clinical consequences reported by the health establishment.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Investigation: details state "when placing a stent in the iliac artery, the balloon of the stent deflates with great difficulty: passage through the introducer in force." the device in question was returned and reviewed to determine the cause of the complaint.The catheter shaft was in good condition with no signs of damage.There were no kinks or areas on the catheter shaft that would have prohibited the flow of fluids through the shaft.The balloon was also in good condition and showed no signs of damage or fluid within the balloon.The catheter shaft showed no signs of elongation or stretching, which is often observed when withdrawal is initiated prior to full deflation, placing resistance and force on the balloon and shaft.The user reported that there was no balloon rupture during deployment and no blood was observed entering the syringe during deflation.To confirm that there were no leaks present in the catheter system, the balloon was inflated to the rated burst pressure of 12atm as indicated on the product label.The catheter was able to withstand this inflation to 12atm without any leaks.Fluid was seen entering the balloon at both the proximal and distal skive holes under the balloon indicating that the lumens were all patent.The skives themselves did not appear to be undersized or damaged in a manner that would prevent the full deflation of the balloon.As the details indicate the balloon deflated with great difficulty the balloon deflation time was evaluated using water and a stop watch.The balloon was inflated to 12atm and deflated fully using the recommended 20cc inflation device per the instructions for use.The balloon deflated fully within 30 seconds.This was repeated for a total of 5 times with the same result.The product requirement document dd008529 product requirements - v12 otw vascular covered stent revision 16, prid# pr-6.2.20 states that the balloon deflation time based on water must be equal to or less than 40 sec for 9 ¿ 10mm diameters.This requirement was met.Several questions were asked of the complainant, including ¿how much time was left for the aspiration of the contrast material from the balloon?¿ the response provided was 10 to 15 minutes, and it was stated that it was not possible to achieve complete deflation.It was stated that a 10cc syringe with manometer and a mixture of 1/3 contrast to 2/3 saline solution was used.The instructions for use (ifu) aw011568 states the following in the preparation section: "step 8.Prepare a 20cc inflation device equipped with a manometer by filling with 10cc of diluted contrast media for 5-10mm diameter balloons; 14cc for 12mm balloons; 16cc for 14mm balloons and 18cc for 16mm balloons.Expel all of the air from the inflation device." the use of a 10cc syringe could decrease the vacuum potential when deflating the balloon, thus increasing the time required to deflate the balloon.The required deflation time would be dependent also on the amount of contrast still within the 10cc syringe during deflation.The amount of contrast in the syringe prior to inflation and deflation was asked of the complainant but was not provided.A bench test was performed to evaluate the impact of using a 10cc inflation device.Using a 10cc syringe completely filled with water at the start of inflation as worst case for vacuum potential, the deflation time increased slightly by approximately 10 seconds over the time observed when using a 20cc syringe filled with 10cc of water as instructed in the ifu.The deflation time with water was still within the 40 seconds required by the product requirements when using the 10cc syringe.Given the use of contrast in the complaint, the overall deflation time can be expected to be longer than with water given the increased viscosity.However, it is still unclear why the balloon would have required 10+ minutes of deflation.Testing performed per dd022271-003, planned engineering study report ¿ evaluating deflation time using contrast/saline media concentration levels of (75%/25%) and (25%/75%), indicates the average deflation time of a 10mmx59mmx120cm device using 75% contrast / 25% saline was approximately 174 seconds (~3 minutes).This represents a larger balloon volume and much higher (more viscous) contrast ratio than used in this complaint.The average deflation time when using 25% contrast / 75% saline, which is more in line with the contrast ratio reported in the complaint, was approximately 43 seconds.Other possible factors that could have affected the deflation could be that if the inflation device was used with a stopcock that had a poor connection or was partially closed; however, this is conjecture only as no information was provided in this regard.A review of the device history records going back to the catheter shaft extrusion subassembly level shows that there were no non-conformances noted and the product met all quality and performance requirements.Based on the review of the device history records there is no indication that a design, manufacturing specification, test method, manufacturing process, equipment or raw material was the cause of the complaint.As the product functioned properly and deflated within the specifications per the product requirement¿s document when prepared in accordance with the ifu, and there were no issues or nonconformances issues related to the complaint identified within the dhr review, the complaint cannot be confirmed.Although there was a potential use error reported in the complaint details, the complaint was unable to be replicated.Therefore, the root cause is impossible to define.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.

• 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: 15796350
• MDR Text Key: 307568972
• Report Number: 3011175548-2022-00353
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85364
• Device Catalogue Number: 85364
• Device Lot Number: 488832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 99 KG