MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS I-CAST; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85418

Device Problem Material Rupture (1546)

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

Event Date 02/11/2022

Event Type  malfunction  

Event Description

Report received stated during a procedure for an illiac occlusion, with shockwave used prior for pre-dilation.The icast was inserted afterwards along with another balloon on the contra side.Both were expanded together.Icast balloon ruptured before getting to atm.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Manufacturer Narrative

Additional information section: a2, a3 & d9.

Event Description

N/a.

Manufacturer Narrative

Investigation: the complaint details state: "during hospital procedure on (b)(6), iliac occlusion with shockwave used prior for pre-dilation.Icast was inserted afterwards along with another balloon on the contra side.Both were expanded together.The icast balloon ruptured before getting to 8atm." a review of the returned device was conducted.The balloon does not appear to have been inflated and is blood stained throughout.The balloon when pressurized was able to reach 8atm however the pressure dropped back to 0atm quickly.A 2mm long radial tear was found half way between the distal transition zone.The balloon appears to have been damaged to cause a radial tear at so low of a pressure.The claim was that the balloon ruptured prior to reaching 8atm however the balloon did not appear to have been inflated at all.The details of the complaint in a response from the complainant show that another catheter was used during the procedure that may have come in contact with the icast coved stent delivery system as the notes provided indicate that the icast was deployed simultaneously with another device however the description of the device was not provided.The details also mentioned that the lesion being treated was highly calcified and required the use of a shockwave catheter prior to the use of the icast to break up the calcification.The response indicated that 50% lumen patency was achieved.If only 50% was achieved it suggest that the lesion was still present and calcified.Based on this added information the most probable cause of the balloon rupture is that the balloon was damaged by calcification in the area to be treated that required the shockwave ivl catheter and treatment designed specifically for use with highly calcified lesions prior to placing a stent.The instructions for use aw010835-en revision aa contraindication states; "non-compliant obstructions where full expansion of a balloon dilatation catheter cannot be achieved during pre-dilation, or where obstructions can not be dilated sufficiently to allow passage of the delivery catheter." based on the details of the complaint and the physical evaluation of the product, the complaint can be confirmed, as the investigation did confirm the described damage imparted during the clinical procedure.The evaluation of the returned device did not reveal any indication that the device in question was faulty or manufactured improperly.Based on this investigation the most likely root cause of the difficulties experienced is operational context.A complaint trend review was conducted to identify complaints with the same reported defect.Two time periods were reviewed to capture the 15 months leading up to the event, as well as following the event.There was one excursion identified for the month of october 2021 for which a capa request was initiated.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 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.

• Brand Name: STENTS I-CAST
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 13619638
• MDR Text Key: 289257272
• Report Number: 3011175548-2022-00094
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854183
• UDI-Public: 00650862854183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2024
• Device Model Number: 85418
• Device Catalogue Number: 85418
• Device Lot Number: 470033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male