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

Model Number 85360

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician attempted to advance the stent through a 7fr cook sheath.This was stent 3 of 3 tracking through this sheath.Stent 1 and 2 advanced and deployed normally.Stent 3 advanced through the sheath valve but was not able to track midway up the sheath.Surgeon proceeded to remove the stent but was unable to remove from sheath and ended up jammed in the hub.The surgeon had to remove the sheath and stent as one unit from the patient.

Event Description

N/a.

Manufacturer Narrative

The product was received and inspected.Upon inspection, the device was very clean and did not appear to be damaged.The stent was in good condition and did not appear to be deformed.The advanta v12 10mm x 38mm catheter was prepped per the instructions for use.A.035" cordis guidewire was placed through the catheter and the device attempted to be passed through the cook 7fr introducer sheath.The stent was advanced into the sheath but became stuck at about 15cm into the sheath.The device was then removed from the introducer sheath.The crimped stent was then measured using a 3 axis laser micrometer, equipment number 8553 calibration due date sep 2021.The maximum outer diameter measured was 2.62mm with an average of 2.58mm.The requirement from the user requirement document for the advanta/icast otw vascular covered stent states ¿product must be able to advance in typical anatomy over a guidewire and through the accessory device/s to target lesion." and is considered a fundamental product requirement.The product requirement document v12 otw vascular covered stent design requirement description is as follows: ¿device must pass through standard introducer sheaths/guides as specified without stent dislodgment or catheter damage.In this regard the stent must be able to be placed through the introducer sheath¿.Every label of the advanta v12 specifies what size sheath should be used for the particular advanta v12 being used.In this case the device was a 10mm x 38mmx 80cm and requires a 7fr introducer sheath.A review of the crimped stent diameters of the advanta v12 production lot of catheters l/n 452930 and subsequent assemblies shows that the measured crimped stent diameter of 20 samples measured during the lot qualification testing was on average 2.48mm with a maximum diameter of 2.55mm.There have been no other complaints for this lot of catheters.There have been no changes to the user requirements or product requirements related to the stents ability to pass through the labeled introducer sheath.The review of the dhr for stent crimping shows that the equipment was properly set up and functioning properly at the time of manufacture.A review of the device history records was also conducted.During the process of manufacturing a sampling of devices is performance tested to ensure the integrity of the product from every production lot of catheters produced.The sampling is based on an aql sampling based on product lot size.Typically, 20 samples are tested from every product lot.The nonconformance report shows that there has not been an incident during the product performance testing where an advanta/ icast covered stent was unable to be advanced through the introducer sheath.Based on the inability to pass the stent through the introducer sheath this complaint has been confirmed.There is currently a corrective and preventive action in place to evaluate the cause.

• 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: 11070034
• MDR Text Key: 224251920
• Report Number: 3011175548-2020-01500
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: 85360
• Device Catalogue Number: 85360
• Device Lot Number: 452930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7 FR COOK SHEATH
• Patient Age: 67 YR