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

Model Number 85329

Device Problems Material Rupture (1546); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report received stated that the v12 balloon ruptured in the introducer 7f sheath.The introducer sheath was withdrawn immediately.No patient consequences.

Manufacturer Narrative

Upon review of the returned device it was clear that the balloon had not been fully deflated before pulling the balloon back through the introducer sheath.The distal end of the balloon was still open.When there is fluid still remaining in the balloon, when the catheter is pulled back into the sheath the fluid gets pushed to the distal end of the balloon creating a plug at the end of the sheath.This is seen in the photo attached to this complaint.If too much force is applied the shaft will stretch and break at the proximal balloon weld as seen in this complaint.In an attempt to determine if the balloon had a leak within it preventing the balloon from fully deflating the remaining portion of the proximal weld was placed inside a toughy borst adapter and the distal tip of the catheter clamped with forceps.The balloon was pressurized.During pressurization fluid could be seen entering the balloon at both the proximal and distal skives in the shaft under the balloon indicting that both lumens were patent.While the balloon was still full of fluid the toughy borst adapter removed and the shaft clamped with forceps.Steady finger pressure was used and there were no visible leaks in the balloon noticed.The separated catheter portion that still had the manifold attached to it was also evaluated.The shaft at the proximal weld area had necked down to a smaller diameter of approximately.042" due to the force imparted on the catheter shaft prior to breaking at the proximal balloon weld area.A syringe full of water was connected to the inflation port of the manifold and the catheter flushed.Fluid was seen coming out of both inflation lumens indicating the there were no blockages and that both lumens were patent.The review of the device history record (dhr) included looking at the skive dimensions of the proximal and distal skive ensuring they were within specification.All dimensions were within specification as listed within the dhr.During the process of manufacturing each skive is inspected to ensure it is in the correct location and an aql level measured to ensure the dimensions were correct.All samples manufactured, evaluated and measured passed all requirements.The proximal balloon weld tensile test data was also reviewed.The break force or tensile test of the proximal balloon weld is tested as part of the lot qualification testing.Per the part specification drawing the minimum allowable tensile break force is 15 newtons.The test data reviewed within the dhr showed that the minimum break force seen was 27 newtons.This exceeds the 15 newton minimum requirement.There were no nonconformance's noted during this build of catheters at any level of manufacture during the build of this catheter lot.Based on the review of the device history records there is no evidence that the device in question was faulty.The dhr review has not shown that the product did not meet requirements nor did the inspection of the physical product.Based on the details of the complaint and the returned device it appears as if the balloon was not allowed sufficient time to deflate prior to withdrawal.In this regard there is no evidence to conclude that the advanta v12 was faulty and therefore cannot confirm the complaint.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

The subject catheter was returned and evaluated.The correspondence in the complaint record indicate the stent was successfully deployed.Upon review of the returned device it was clear that the balloon had not been fully deflated before pulling the balloon back through the introducer sheath.The distal end of the balloon was still open.When there is fluid still remaining in the balloon and the catheter is pulled back into the sheath the fluid gets pushed to the distal end of the balloon creating a plug at the end of the sheath.This is seen in the photo attached to this complaint.If too much force is applied the shaft will stretch and break at the proximal balloon weld as seen in this complaint.In an attempt to determine if the balloon had a leak within it preventing the balloon from fully deflating the remaining portion of the proximal weld was placed inside a toughly borst adapter and the distal tip of the catheter clamped with forceps.The balloon was pressurized.During pressurization fluid could be seen entering the balloon at both the proximal and distal shives in the shaft under the balloon indicting that both lumens were patent.While the balloon was still full of fluid the toughy borst adapter removed and the shaft clamped with forceps.A finger was used to apply steady pressure to the inflated balloon, and there were no visible leaks in the balloon noticed.The separated catheter portion that still had the manifold attached to it was also evaluated.The shaft at the proximal weld area had necked down to a smaller diameter of approximately 0.042 inches (from approximately 0.060 inches) due to the force imparted on the catheter shaft prior to breaking at the proximal balloon weld area.A syringe full of water was connected to the inflation port of the manifold and the catheter flushed.Fluid was seen coming out of both inflation lumens indicating the there were no blockages and that both lumens were patent.Based on the details of the complaint and the returned device it appears as if the balloon was not allowed sufficient time to deflate prior to withdrawal.The complaint can be confirmed in that the balloon had been "ruptured" i.E.Separated from the catheter shaft.However, the failure cannot be linked to the manufacture of the product.The review of the device history record (dhr) included looking at the skive dimensions of the proximal and distal skive ensuring they were within specification.All dimensions were within specification as listed within the dhr.During the process of manufacturing each skive is inspected to ensure it is in the correct location and an aql level measured to ensure the dimensions were correct.All samples manufactured, evaluated and measured passed all requirements.The proximal balloon weld tensile test data was also reviewed.The break force or tensile test of the proximal balloon weld is tested as part of the lot qualification testing.Per the part specification drawing the minimum allowable tensile break force is 15 newtons.The test data reviewed within the dhr showed that the minimum break force seen was 27 newtons.This exceeds the 15 newton minimum requirement.There were no nonconformances noted during this build of catheters at any level of manufacture during the build of this catheter lot.The dhr review has not shown that the product did not meet requirements nor did the inspection of the physical product.A complaint trending review revealed that there have been numerous occurrences of this or similar failure modes and a capa has been initiated by the manufacturer, and is in the implementation phase.There have been reports of difficult withdrawals, as well as separation of the balloon and/or manifold from the rest of the catheter shaft during withdrawal.The most significant factor leading to the issue identified in the investigation performed for this capa 429004 was fluid remaining in the balloon during removal.The most probable cause of this was found to be insufficient time for the balloon to deflate prior to removal.With the use of contrast, the advanta v12 deflation time can take longer than the 40s as specified in the ifu for larger size balloons.The catheter design/deflation specification was developed using water as an inflation medium.Contrast has a higher viscosity than water resulting in longer deflation times.If adequate deflation time is not provided and full deflation of the balloon is not verified via fluoroscopy in accordance with the ifu prior to withdrawal, this can lead to excessive force being applied to the catheter when removing the catheter back through the sheath following stent deployment and placement.These findings have been assessed via hhe2021005 and a field action plan was initiated in february 2022.Based on the details of the complaint and investigation conducted, it is likely that this complaint is of the same root cause as that identified in ongoing capa 429004 noted above, which is currently in the implementation phase.The evaluation of the returned device showed that the distal part of the balloon was still open, indicating the balloon was not fully deflated.Additionally, the subject device was a 9mmx59mm balloon, which is one of the largest volumes.These details are consistent with the findings of capa 429004.

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: 12648597
• MDR Text Key: 281218039
• Report Number: 3011175548-2021-01059
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85329
• Device Catalogue Number: 85329
• Device Lot Number: 471967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1076-2022
• Patient Sequence Number: 1