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

Model Number 85328

Device Problem Difficult to Remove (1528)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

V12 stent deployed successfully.Post deployment when surgeon was removing the catheter with balloon intact back through sheath, the catheter tip broke off.Tip was retrieved and removed with sheath.

Manufacturer Narrative

Based on the details of the complaint v12 stent deployed successfully.Post deployment when surgeon was removing the catheter with balloon intact back through sheath, the catheter tip broke off.Tip was retrieved and removed with sheath.The product was not returned and no images were provided of the device, therefore the reported complaint could not be confirmed.Additional information received stated no further details would be provided and the surgeon did not find the issue to be a fault of the product.The review of the device history records did not exhibit any no non-conformances during the manufacture of this lot of advanta v12 catheters.During the process of manufacturing twenty (20) samples of the catheter tips were tensile tested to ensure the tips are attached properly and met the product requirement specifications.The lowest tip tensile detachment force noted in the device history record is 12.4 newtons.Per the "product requirements - v12 otw vascular covered stent" the requirement is that the tensile force must be at a minimum of 10 newtons.Traditionally there is no tensile loading of the soft distal tip of the catheter upon withdrawal of a catheter during a clinical procedure.During the procedure a guidewire is also placed through the length of the catheter.To detach the tip of the catheter excessive force would have needed to be applied.Based on additional information provided from the surgeon there is no reason to conclude that the device was the cause of the reported incident.H3 other text : device not available for return.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11936565
• MDR Text Key: 254471527
• Report Number: 3011175548-2021-00606
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

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: 06/23/2023
• Device Model Number: 85328
• Device Catalogue Number: 85328
• Device Lot Number: 461548
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 10/19/2021
• Patient Sequence Number: 1