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

Model Number 85365

Device Problem Difficult to Insert (1316)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

Customer reported that the balloon of the advanta v12 could not be completely dilated (pressure drop) this was characterized by blood aspiration over the balloon.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: the details provided are the following, "customer reported by phone that the balloon could not be completely dilated (pressure drop) this was characterized by blood aspiration over the balloon." follow up details indicate "the aim of the operation was to eliminate a 4.6 cm large a.Iliaca comm.And 3.6cm internal iliac aneurysm with an iliac side arm prosthesis (cook 12-45-41) and aortobilical stent graft.The aii aneurysm was >8 long to the anchoring zone, so implantation of 2 overlapping 10 x 59mm v-12 stents was planned." the device is question was returned and evaluated.Upon removing the device from the bag it was received in the stent on the distal end had seem positive pressure however the end of the stent was badly deformed.The proximal end of the stent had not seen positive pressure and one of the end cells of the stent had been folded backwards upon itself.The balloon under the stent was also evaluated.The distal balloon cone again had seen positive pressure but not enough to fully deploy the stent.The stent was then removed and the balloon of the catheter pressurized.Upon inflation using a 20cc inflation device a balloon hole was noted at the point where the stent ends at the distal balloon cone.During inflation approximately 4atm was achieved before the balloon pressure dropped.Under magnification the hole in the balloon was evaluated.Based on this review it would appear as if the balloon had been punctured as the material surrounding the area was clean but protruding inward.There are no visible scratched on the surface of the balloon or in the surrounding area f the balloon hole.As this device was used in a case within a vascular graft with an extension into the internal iliac it is likely that the balloon was ruptured when navigating through the vascular graft, possibly on a vascular graft fixation barb as the access to this location was made contralaterally from the left femoral artery over the iliac arch to the right external iliac.Images provided show the vascular graft was not fully deployed.The complaint has been able to confirm that the balloon was compromised at some point during the procedure but could not confirm that the device in question was manufactured with a hole in the balloon.Trend review was completed and there was one escalation in oct 2021 for exceeding the 3 stddev escalation point and was issued corrective action request number cr588015.This was not escalated to a capa did not identify any excursions.The historical review also identified potentially related ncrs and an ongoing capa 322474 addressing manufacturing related defects.The investigation of this complaint however, has determined the most likely cause to be procedural, and unrelated to manufacture of the device.A dhr review was completed which did not find any non conformances during the manufacturing process of this lot.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.

Event Description

N/a.

Manufacturer Narrative

Additional information.

Event Description

N/a.

Manufacturer Narrative

Additional information.

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: 14754002
• MDR Text Key: 296142724
• Report Number: 3011175548-2022-00173
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• 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,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85365
• Device Catalogue Number: 85365
• Device Lot Number: 476260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK ZENITH BRANCH ENDOVASCULAR GRAFT.; UNKNOWN.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 90 KG