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

Model Number 85345

Device Problem Material Rupture (1546)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Surgeon performed a right common iliac artery (rcia) angioplasty (+/- stent).Accessed via the right groin, performed an atherectomy using a jetstream (boston scientific) through proximal end of rcia, then in some areas of the right external iliac artery as these areas were occluded with calcified plaque.Used a ranger drug coated balloon (boston scientific), to balloon the area that was intended to be stented - removed balloon.Tracked v12 stent (7x22x80) through 7 fr destination sheathe (terumo) to the area of deployment (proximal rcia), began deploying/ inflating balloon, balloon ruptured at 6 atmospheres.Removed balloon, used a boston scientific balloon to post dilate stent, which deployed as normal.No injury or harm caused to patient.The surgeon acknowledged that the area of stent deployment had very calcified plaque.

Manufacturer Narrative

Additional information section d.9.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Based on the information provided regarding the procedure the physician stated the following: ¿never experienced a v12 deployment balloon rupturing before.Acknowledged that the area of stent deployment was very calcified plaque, could perhaps have been that, but not certain¿.The returned product was evaluated to determine the root cause of the complaint.Upon removal of the device from the returned box, a macroscopic examination was done and no defect could be identified.The catheter was pressurized using a 20cc syringe with a 25atm gauge and it was observed that a thin stream of water continuously ejected from the balloon at the distal end of the dilatation zone of the balloon prior to the distal radiopaque marker band.Upon microscopic inspection, a pinhole tear in the balloon was noted.In the area of the hole in the balloon there appears to be what can be described as a puncture site or area of deformation surrounding the rupture site.This is indicative of a rupture caused by an outside force such as the described calcification by the physician.The instructions for use in the contraindication section states the following: ¿heavily calcified lesions resistant to pta¿.A review of the device history records shows that this lot of catheters passed all quality and performance requirements.There were no non-conformances noted during the manufacture of the product and no material, design, manufacturing or equipment issues have been identified that would have contributed to the reported complaint.Product lot qualification testing is done on every lot of catheters.As part of the testing, the stent delivery system is pressure integrity tested to ensure the system can withstand the rated burst pressure of the device.The labeled rated burst pressure for this product is 12 atm as noted on the product label.The requirement of a burst pressure of = 12 atm is also specified in the product requirement document.A review of the dhr shows that the minimum burst pressure was noted as 20.44atm, which passes the pressure integrity test.A review of the dhr for balloon forming shows that the minimum burst pressure was 20.16atm, which is also within specification limits.The information provided in the complaint, images provided, and the evaluation of the returned product, there is no evidence to conclude that the device was faulty, therefore the complaint cannot be confirmed.The product met all quality and performance requirements.The thorough review of the device history records has not identified any non-conformances during the manufacture of the product.Based on the complaint details and investigation results it is most likely that the balloon tore on the calcified lesion as referenced in the details provided by the surgeon (¿area of stent deployment was very calcified plaque, could perhaps have been that, but not certain¿), which is identified as a contraindication in the ifu for the product (¿heavily calcified lesions resistant to pta¿).

• 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: 12362980
• MDR Text Key: 268052294
• Report Number: 3011175548-2021-00880
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2023
• Device Model Number: 85345
• Device Catalogue Number: 85345
• Device Lot Number: 467347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/15/2021; 01/14/2022
• Supplement Dates FDA Received: 09/23/2021; 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JETSTREAM, TERUMO 7FR SHEATH.
• Patient Sex: Female