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

Model Number 85365

Device Problem Material Separation (1562)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Follow-up report will be submitted upon completion of the investigation.

Event Description

The surgeon was pushing the stent through a long 7 french sheath and the stent became stuck and would not move in either direction.The surgeon aimed to remove the stent and upsize to an 8 french sheath, but when he tried to pull the stent out, the tip of it broke off.Both of the stent pieces and the 7 french sheath were removed from the patient without patient injury.

Manufacturer Narrative

Based on the details of the complaint the advanta v12 was attempted to be delivered through a 7fr introducer sheath but became lodged inside the sheath.Upon withdrawal the claim was that the tip of the catheter broke off.The device in question was not returned and there were no images of the device provided.Multiple attempts to obtain more detailed information about the complaint were attempted but unsuccessful.A review of the device history records shows that this manufacturing lot of advanta v12 covered stents passed all quality and performance requirements prior to being packed.This includes the tensile and elongation testing for the tip of the catheter distal weld as well as the proximal balloon weld where the balloon is thermally attached to the catheter shaft.The part specification documentation shows that the specification for the proximal weld tensile strength is a minimum of 15 newton¿s (n).The actual data of the 20 samples tested in process shows that the minimum tensile value was 25 n.The minimum tensile requirement for the distal weld tip is 10 n.The test data minimum test value seen was 11.6 n.In both the proximal and distal welds, the product met the requirements of the part specification.It is important to note that there would be no tensile loading of the distal weld to tip within the introducer sheath while withdrawing unless the introducer sheath used was kinked.As the device became lodged within the sheath, a review of the crimped stent data was also reviewed.This data shows that all 20 samples tested pass the requirement whereas 20 samples were placed through the required 7fr introducer sheath during the lot qualification testing.All catheter assemblies were able to pass through the labeled introducer sheath.A recent change to the instructions for use has been conducted.Although the introducer sheath is not known in regards to this complaint, the instruction's for use added the following warning and caution: "always consult the product label to ensure a compatible sheath is selected for use.Do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.Forcing passage can result in damage to the stent or balloon catheter, stent dislodgment from the balloon, or separation of the catheter components.If using a 10mm device with a cook introducer sheath, it is recommended to size up to an 8 french sheath to minimize potential for resistance." without the return of the device for evaluation, images of the procedure and additional details the root cause cannot be determined and the complaint cannot be confirmed.H3 other text: device not available for return.

Event Description

N/a.

• Brand Name: STENTS ADVANTA V12
• 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: 12325649
• MDR Text Key: 266701742
• Report Number: 3011175548-2021-00846
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

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: 05/07/2023
• Device Model Number: 85365
• Device Catalogue Number: 85365
• Device Lot Number: 459788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7 FRENCH SHEATH; 7 FRENCH SHEATH