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

Model Number 85352

Device Problems Accessory Incompatible (1004); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Interventional radiologist was introducing a 6 mm x 16 mm v12 stent through a 6.5 fr aasahi sheathless introducer to stent a celiac artery.On advancement radiologist described resistance then a "slip".The stent was partially displaced from balloon.Removed and procedure abandoned.Case rescheduled.

Manufacturer Narrative

Correction section: d.9 - device available for evaluation "no" product was not returned.The product in question was not returned and no images were provided of the catheter or the guide catheter used in the case.As part of the investigation, a review of the accessory device used in the case was conducted as the details mention that the introducer was too narrow.The fact that a guiding catheter was used instead of an introducer sheath is important as guide catheter dimensions are completely different than an introducer sheath.The product label for a 6mmx16mm advanta v12 covered stent requires the use of a 6 french introducer sheath.This relates to an inner diameter of the sheath being 2.0mm based on a standard french size scale.The product label displays the image of the introducer sheath with the text 6fr (2mm).The 6.5 french asahi sheathless introducer is actually a guide catheter and has an outside dimension of 6.5french or 2.13mm.The inner lumen is listed as being 0.070¿ or 1.778mm.A review of the dhr for the affected lot indicates the averaged crimped stent diameter (taken for reference only on 13 samples) was approximately 2.15mm , which is inline with historical design verification data for the 6 fr compatible stent sizes.The tolerancing in introducer sheath sizing allows for some interference fit.Each production lot is functionally tested for passage through the labeled introducer sheath before release.However, given that an accessory device smaller than labeled was utilized for the case, this explains why additional resistance was felt during insertion, as the advanta v12 would not be compatible with this accessory.Although the device was not returned and no images were provided for evaluation, we can consider this a confirmed event, given that a use error occurred as indicated in the complaint details.An incompatible accessory device was utilized for the case, resulting in a stent dislodgement.It cannot be confirmed, however, that the device was nonconforming or at fault.A trend review was completed which did not identify any excursions.A review of the device history records going back to the sub assembly level where the balloon is formed shows that there were no non-conformances noted and the product met all quality and performance requirements.This includes the advancement of the crimped stent through the labeled introducer sheath and stent deployment of 13 catheter units without stent movement or stent deployment issues.The testing also conducted, as part of the product lot qualification is stent retention testing of three units.The minimum stent retention data point was 10.5 newtons.Per the part specification ps010635-xxx ps,stent delivery system,otw,v12/icast,3l,5-7mmx16/22mm revision ab the specification for stent retention is = 2.9 newtons.This requirement was met.There is no indication that any manufacturing deficiency was the cause of the event.The ifu gives instructions not to force passage or withdrawal of the device.This correlates to the mitigation within the dfmeca noted above.The product label also specifies the use of a 6fr introducer sheath (inner diameter 2.0mm).In this particular case a 6.5fr coronary guide catheter was used, with an inner diameter of 1.78mm.The labeling information provides adequate instruction for proper use of the device.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.Based on the findings of this investigation, no escalation is needed or corrective actions as the root cause is associated with the physician using a 6.5 fr guide catheter and not a 6fr introducer sheath.H3 other text : device not returned.

Event Description

N/a.

• 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: 11042138
• MDR Text Key: 222708136
• Report Number: 3011175548-2020-01464
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2023
• Device Model Number: 85352
• Device Catalogue Number: 85352
• Device Lot Number: 458502
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6.5 FR AASAHI SHEATHLESS INTRODUCER