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

Model Number 85353

Device Problem Material Integrity Problem (2978)

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

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the balloon ruptured before it was even inflated.Not sure if it was defective or not.

Manufacturer Narrative

Additional information.

Event Description

Per information received: procedure was a right renal angioplasty/stenting, blood was noticed in the balloon port upon unsheathing the stent prior to inflation.Procedure needed to be rescheduled due to no other available stents on site.

Event Description

N/a.

Manufacturer Narrative

The details provided regarding this complaint are the following: "the balloon ruptured before it was even inflated".Additional information provided was that the device had been placed through a 6fr straight terumo destination sheath and the intended target was the right renal artery that had a previously placed stent of unknown origin.Upon exposing the stent outside the introducer sheath blood was seen entering the balloon port.It is not clear if the balloon made contact with the previously deployed stent however if the balloon had made contact with the metal frame of the previously deployed stent there is a possibility that the stent ruptured the balloon of the advanta v12 during the approach and/or positioning of the stent.The product in question was unfortunately not returned and there were no images from the procedure to aid in the investigation.Without this key information the complaint cannot be confirmed.A device history record review was conducted down to the balloon tube assembly level all the way up to the finished good assembly level.This review verified that all product met the quality and performance requirements specified on each device history record.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.The capa review did identify one ongoing capa related to balloon pinhole defects from the crimping process.It is unknown if this complaint is related; however, given the device use in conjunction with a previously deployed stent, the most likely cause is operational context.Based on the details of the complaint and investigation results the complaint cannot be confirmed.There is no evidence to conclude that the advanta v12 was at fault or manufactured with a defect that would have lent itself to the balloon rupturing or leaking during the procedure.Based on the results of the investigation the most probable root cause is operational context, as it is possible the balloon was damaged while attempting to pass or position the stent through a previously deployed stent.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: 15225446
• MDR Text Key: 304983134
• Report Number: 3011175548-2022-00235
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85353
• Device Catalogue Number: 85353
• Device Lot Number: 477559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6FR 45CM STRAIGHT TERUMO DESTINATION SHEATH.
• Patient Age: 55 YR
• Patient Sex: Male