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

Model Number 85337

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

Vascular surgeon wanted to let getinge know that the balloon on the atrium stent ruptured this morning.Unsure why, the arteries didn¿t appear calcific.She was able to get another balloon back inside the stent and inflate to post dilate.

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Manufacturer Narrative

Investigation: vascular surgeon wanted to let getinge know that the balloon on the atrium stent ruptured.Unsure why, the arteries didn¿t appear calcified.She was able to get another balloon back inside the stent and inflate to post dilate.No other details were provided.Multiple attempts were made to obtain additional information regarding the complaint and procedure to help determine the cause of the alleged balloon burst but no answers were provided.The device in this case has not been returned.Photos of the device were also not provided.Based on the details provided it is impossible to confirm if the balloon or catheter was leaking at the time of the attempted stent deployment.A review of the inventory for this lot of product shows that there is no inventory left to conduct testing on a companion sample.Additionally, as the circumstances surrounding the alleged incident were not provided, testing of a contemporaneous sample will not be performed as the clinical procedure details will not be able to be replicated.Without the device in question, the complaint cannot be confirmed nor can any device nonconformity.A recurring lot number query was conducted and there has been no other complaints associated with this lot of stent delivery systems (l/n 483942).A complaint history, complaint trend, and capa review did not identify any related complaints, capas, or trends to specifically aid in the investigation.The device history records review did not identify any non-conformances.All product quality and performance requirements were met.All equipment was in calibration and the records show that all personnel were properly trained to the procedures.No significant design, material, procedural or process changes around the time of device manufacture have been identified.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 information provided in the complaint and the review of the device history records, there is no evidence to conclude that the device was faulty or manufactured improperly.Based on the investigation the root cause is impossible to define.The product met all quality and performance requirements.H3 other text : device not returned.

• 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: 16712418
• MDR Text Key: 313015380
• Report Number: 3011175548-2023-00095
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85337
• Device Catalogue Number: 85337
• Device Lot Number: 483942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8X59 ON 120CM SHAFT