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

Device Problem Inaccurate Information (4051)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A physician reported that the official data of the technical data sheets of the product regarding the real outer diameter isn't the same as our brochure.He would like a statement on how he will be able to reach a 16 mm diameter.

Event Description

The complainant was an endovascular surgical assistant not a physician.

Manufacturer Narrative

Based on details provided by an endovascular surgical assistant who reported that the official data of the technical data sheets of the product regarding the real outer diameter isn't the same as our brochure.He would like a statement on how he will be able to reach a 16 mm diameter and why we have this misinformation.The product label of the advanta v12 provides a stent recoil chart.This recoil chart provides the physician with dimensions that he/or she can expect after the deployment of the stent to nominal inflation pressures also listed on the product label.Recoil is the percentage by which the diameter of a stent decreases from its expanded diameter (when the balloon is inflated at the nominal pressure) to its relaxed diameter (when the balloon is retrieved from the stent).The stent¿s ability of opening the occluded lumen is adversely affected by the radial recoil; thus the stent is usually over-expanded by 10%¿20% of the reference lumen diameter to compensate for the elastic recoil of the stent.As with most every balloon expandable stent there will be recoil of the stent once expanded, hence why we have this chart on the front label of the package.Atrium medical provides the stent on a 12mm balloon platform.What this means is the stent is deploy on a 12mm balloon so at nominal pressure of 8atm the balloon and stent will reach 12mm in diameter, however once the balloon is deflated the stent will recoil down to a diameter on ¿average¿ of what is defined in the table on the provided label.Within the instructions for use there is a separate table.This table is titled "max recommended post dilation (mm)" that comes with a warning that reads: for the maximum recommended post dilation diameter, reference the table in the attached ifu.Post dilation greater than the recommended diameter may result in the fracture of the stent causing serious injury or death." this table says for all labeled 12mm product, the stent can be post dilated to 16mm.Atrium medical does not provide a balloon catheter that would bring this stent up to 16mm however, the chart is simply provided to ensure the stent is not dilated above 16mm.There was no of a device issue or any patient involvement and it was just an inquiry on use.Atrium provides the most information on recoil/foreshortening as compared to the main competitors.As seen on the atrium labeling stent sizing, the final stent diameter and length data is provided in accordance with post dilation diameter.Based on the reported information and review of the instructions for use a deficiency cannot not be found and this reported complaint cannot be confirmed.H3 other text : no actual device failure reported.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10777441
• MDR Text Key: 216117352
• Report Number: 3011175548-2020-01325
• 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,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1