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

Model Number 85360

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/27/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the placement of the stent, after the release, the balloon became detached from the device.The balloon recovered with forceps, because device placed after endarterectomy, therefore open.

Event Description

N/a.

Manufacturer Narrative

Additional information.

Manufacturer Narrative

Based on the details of the complaint 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 a 1/3 to 2/3 contrast to saline mix ratio was used in the balloon.In regards to the amount of time allowed for the balloon to deflate the answer received was ¿30 seconds¿.The response also mentions that the balloon was ruptured when deploying the stent and blood was seen in the syringe.It is not known how the balloon ruptured or if it was visualized to be fully deflated under fluoroscopy as mentioned in their response prior to attempting to remove the catheter.If the balloon had ruptured as described full deflation of the balloon would not have be able to be achieved.As such, given the large volume balloon 10x38mm, it is also possible that the 30 second deflation time was insufficient based on the findings of the capa described below.A review of applicable device history records was conducted.There were no nonconformances 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: not returned.

Event Description

N/a.

Manufacturer Narrative

Corrected section: h.1 - type of reportable event was inadvertently selected as malfunction on mdr follow-up #1 & #2 corrected to serious injury as stated in the initial mdr.

• 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: 13285939
• MDR Text Key: 284507448
• Report Number: 3011175548-2022-00029
• 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: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/16/2023

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 Model Number: 85360
• Device Catalogue Number: 85360
• Device Lot Number: 476996
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 01/24/2022; 05/22/2022; 01/14/2023
• Supplement Dates FDA Received: 02/23/2022; 06/08/2022; 01/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1076-2022
• Patient Sequence Number: 1
• Treatment: 7F COOKMEDICAL. ARMADA BALLOON.TERUMO GUIDE.; UNKNOWN.
• Patient Outcome(s): Required Intervention