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

Model Number 85326

Device Problem Difficult to Remove (1528)

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the balloon did not deflate well at the time of the withdrawal which led to a separation.

Event Description

N/a.

Manufacturer Narrative

The complaint details state that the balloon did not deflate well at the time of the withdrawal which led to a separation of the balloon.Based on these details, upon attempting to withdraw the device the balloon became stuck in the introducer sheath and separated from the catheter shaft.The provided information shows that when asked ¿what was the ratio of saline vs.Contrast¿, it was noted 1/3 to 2/3.In regards to the amount of time allowed for the balloon to deflate the answer received was ¿less than 10 seconds¿.The response also mentions that the balloon was visualized to be fully deflated prior to attempting to remove the catheter.Full deflation of the balloon within 10 seconds or less is not possible based on the size of balloon and contrast used, and the balloon would not appear to be fully deflated within this time frame under fluoroscopy.The device was not returned for evaluation.A review of applicable device history records was conducted.There were no non-conformances noted during any of the device builds and no indications of any manufacturing defect that could have contributed to the issue.Based on the details of the complaint and investigation conducted, it is likely that this complaint is of the same root cause as that identified in ongoing capa 429004, such that it is likely that the balloon was not allowed sufficient time to deflate prior to withdrawal of the balloon and/or was not visualized to be fully deflated under fluoroscopy.When there is fluid still remaining in the balloon, when the catheter is pulled back into the sheath the fluid gets pushed to the distal end of the balloon creating a plug at the end of the sheath.If too much force is applied the shaft will stretch and break near the proximal balloon weld and/or the manifold hub.It is for this reason that the most probable root cause is operational context.A secondary root cause is design, based on the findings of capa 429004, as with the use of contrast, the advanta v12 deflation time can take longer than the 40s as specified in the ifu (based on the use of water) for larger size balloons.Capa 429004 is currently in the implementation phase and this issue has been evaluated under hhe 2021005 and is associated with recall number z-1076-2022.H3 other text: device not returned.

• 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: 14164639
• MDR Text Key: 289741748
• Report Number: 3011175548-2022-00127
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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: 85326
• Device Catalogue Number: 85326
• Device Lot Number: 476170
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/22/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1076-2022
• Patient Sequence Number: 1