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

Model Number 85331

Device Problem Material Separation (1562)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a fevar procedure, after deflation of the advanta v12 stent in the renal artery the customer realizes an occlusion of the artery.After retrieval of the sheath they realized that there is no balloon material on it, so they found that the balloon fell off from the catheter and was still in the patient.Kidney was 2 hours without perfusion during several attempts to place an additional stent.Prolonged procedure occurred.

Manufacturer Narrative

An evaluation of the returned device was conducted.The details of the complaint stated that during a fevar procedure, after deflation of the advanta v12 in the renal artery the balloon was missing and in the renal artery.The 7fr terumo introducer sheath was also returned.The sheath at the distal tip was badly deformed and appears as if the deformation noted is all on one side as if the catheter upon withdrawal was at an extreme angle.Upon review of the returned stent delivery system the balloon was no longer on the catheter shaft and had separated from the proximal and distal welds of the catheter cleanly.Both the radiopaque ro marker bands were still in place and not loose.The catheter shaft did not have any signs of damage including stretching of the catheter shaft.The balloon welds were inspected.Both the proximal and distal welds were approximately 3.5mm long and is indicative of a properly welded balloon.The balloon necks when trimmed after balloon forming are cut to 4mm in length.The thermal welding tooling jaws weld area is also 3.5mm.There is no reason to suspect based on the dimensions observed with the weld area that the proximal and distal welds were not conforming.The device history records show that this product lot of catheters passed all quality and performance criteria without and non- conformances.During the manufacture of the device the balloon welds are tested by tensile testing both the proximal and distal balloon welds.The test data for the proximal balloon weld shows that the minimum bond strength recorded was 20.2n.The product specification document states that the minimum allowable tensile strength is 15 n.This requirement was met.The distal balloon weld data shows that the minimum tensile strength noted was 10.6n which met specifications.Based on the details of the complaint it has been confirmed that the balloon had been separated from the catheter shaft however it cannot be confirmed that the device had left the site of manufacturing with a defect that may have contributed to the separation of the balloon from the catheter shaft.The instructions for use (ifu) state in the warnings and cautions section the following: do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.Deflate the balloon by pulling vacuum on the inflation device to its maximum volume for 40 seconds.Verify full balloon deflation via fluoroscopy before proceeding.The details provided indicate that the procedure was a fevar procedure to fix an endograft in the region of the renal artery due to an aortic aneurism.Based on the details of the complaint it appears as if the balloon may have been separated while trying to withdraw the balloon back into the introducer sheath as the sheath deformation suggests based on the deformation noted.The probable root cause is most likely that too much force was applied to the catheter resulting in the balloon separation.Based on the details of the complaint it appears as if the balloon may have been separated while trying to withdraw the balloon back into the introducer sheath as the sheath deformation suggests based on the deformation noted.The probable root cause is most likely that too much force was applied to the catheter resulting in the balloon separation.

Event Description

N/a.

Manufacturer Narrative

Additional information.

Event Description

N/a.

• Brand Name: STENTS ADVANTA V12
• Type of Device: STENT, RENAL
• 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: 12530890
• MDR Text Key: 273303953
• Report Number: 3011175548-2021-01001
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: 85331
• Device Catalogue Number: 85331
• Device Lot Number: 467688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male