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

Model Number 85328

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As passing stent over 0.035 guide wire through a 7 fr sheath stent was getting stuck even when used with force.Surgeon decided to withdrawal stent as it didn't feel right and as he withdrew the stent came off the delivery system.

Manufacturer Narrative

Additional information: h3 other text: not available for return.

Event Description

N/a.

Manufacturer Narrative

The product in question was not returned and none of the questions asked to aid in the investigation were answered by the complainant.There were also no images of the product provided.In this regard the complaint cannot be confirmed.A companion sample was not requested for additional testing as the circumstances surrounding the clinical procedure were not provided including the manufacturer of the sheath used in the case.A review of the device history records going back to the stent sub assembly and balloon subassembly levels 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 without sheath compatibility issues.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.A labeling review was conducted.The device was presumably used in accordance with the approved indications for use.The ifu was found to provide adequate instructions for selection and use of accessory devices for the intended use.Based on the details of the complaint, and the device history records review the complaint could not be confirmed as there was very little detail provided, no images of the device or product returned.No nonconformance with the device has been identified.As such, a root cause for the reported event cannot be determined.The complaint root cause is ¿impossible to define¿.Escalation is not required for this complaint.The complaint has not been confirmed and there is no indication of any nonconformance, nor a design, labeling, manufacturing problem, or procedural/use issue.The complaint is adequately covered in the risk management file, is operating within the approved risk profile, and no adverse trends have been detected.

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: 15057642
• MDR Text Key: 304136137
• Report Number: 3011175548-2022-00192
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2022

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 Model Number: 85328
• Device Catalogue Number: 85328
• Device Lot Number: 477313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 08/08/2022; 11/07/2022
• Supplement Dates FDA Received: 08/08/2022; 11/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.