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

Model Number 85365

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician performed an iliac side branch procedure with a crossover technique.The iliac vessel was very kinked.After placing and deploying the v12 stent distally, it was difficult to pull back the v12 balloon.It stuck in the kinked area guided by a sheath.After pulling back the catheter under strong force the complete balloon tore off from the catheter.The surgeon was very experienced and tried to catch the balloon with a snare and pulled it out of the sheath.

Manufacturer Narrative

A review of the complaint details and images provided were evaluated to determine the cause of the complaint.The additional details that were provided indicated that the procedure was an iliac side branch in crossover technology.The details also provided indicated that "the iliac vessel was very kinked" and that the introducer sheath used in the case was also kinked.The physician stated that there was resistance during the removal of the balloon.Based on the information it is likely that the deflated balloon could not be withdrawn past the kink in the sheath.The sheath used was an 8fr introducer sheath as stated in the complaint details.The recommended introducer sheath for a 10mm x 59mm product is a 7fr introducer sheath as stated on the product label.In this regard, under normal conditions a 10mm x 59mm v12 would easily pass through the larger 8fr introducer sheath.Images of the device were provided and reviewed.The images however are not very clear.The first image is of the separated balloon from the catheter shaft.The balloon appears to have a large bend to it.The balloon also appears to be separated from the catheter shaft at the location of the proximal balloon weld.The distal end of the balloon also appears to be slightly open.The image of the introducer sheath is not very clear and it shows that the dilator was placed back through the sheath.Because the dilator was placed back through the sheath, the kink in the sheath would be pushed back open with the dilator.The third image shows that the catheter shaft of the 10mm x 59mm v12 has seen a tremendous amount of force as the catheter shaft has been stretched significantly.A review of the relevant data within the device history records was also reviewed.Per the product user requirements, the proximal balloon bond must not break at a force below 15n.For the proximal balloon bond to break during withdrawal a force greater than 15 newtons (n) must have been applied while attempting to pull the balloon back through the 8fr introducer sheath.The instructions for use state in the warnings and cautions section the following: "do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered." a review of the proximal balloon bond tensile force data collected during the quality performance testing that every lot of catheters manufactured is subjected to be reviewed to ensure the minimum specification for proximal bond tensile force was met.The review shows that 20 units were proximal balloon bond tensile tested from this catheter lot and the minimum tensile break force recorded was 24.5 n.The minimum allowable break tensile force is 15 n.The minimum break force seen from this production lot exceeds this requirement by almost 10 n.Based on the details of the complaint, images provided and results of the device history records review the root cause of the complaint is considered operational context as the vessel and sheath appear to have been badly kinked that likely prevented the catheter from being able to be withdrawn back through the sheath.There is no evidence to conclude that the device was non-conforming and there were no non-conformances noted during the manufacture of this production lot of the catheters.H3 other text : 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: 10929483
• MDR Text Key: 219194134
• Report Number: 3011175548-2020-01399
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: 85365
• Device Catalogue Number: 85365
• Device Lot Number: 464869
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 82