MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: proksch, daisy.(2021).A comparison of stenting versus hero for hemodialysis patients with recurrent central venous obstructions.Journal of vascular surgery venous and lymphatic disorders.Objective: central venous occlusive disease is a common cause of upper extremity arteriovenous access dysfunction in hemodialysis patients.When refractory to balloon angioplasty, the treatment options include central venous stenting and hemodialysis reliable outflow (hero; merit medical, south jordan, utah) graft.The purpose of the present study was to evaluate the outcomes of these options.Method: a retrospective review was performed of patients who had undergone central venous stenting or hero placement for central venous obstruction from december 2008 to march 2018.The primary outcomes were the reintervention rates, patency, and mortality.Conclusions: central venous stenting and hero were shown to have similar rates of reintervention and patency.The results from the present study suggest that the multiple treatment options available for this problematic disease process can yield similar results when careful patient selection is applied.Per the article adverse events included occlusion, infection.

Manufacturer Narrative

This complaint is based on information within an article and no specific device information has been provided.As there is insufficient details of an actual device malfunction or adverse event that occurred the complaint cannot be confirmed.A device history record (dhr) review was unable to be performed as the device product part number and lot number was not provided within the article.Attempts to obtain the device lot information was conducted but unsuccessful.Conclusion: please note that the use of the device may be related to an off-label use of the icast balloon expandable covered stent, which means that the use has not been approved or cleared by the food and drug administration (fda) as safe or effective.Getinge¿s icast¿ covered stent is fda 510(k) cleared for the treatment of tracheobronchial strictures produced by malignant neoplasms.Although only 8.1% of the stent patients and 22.2% of the hero patients had maintained primary patency at 1 year post procedure and the secondary patency was 53.3% vs 73.9% at 1 year follow-up; at 2 years, 2.7% of the stent patients and 7.4% of the hero patients still had primary patency and 40.0% of the stent patients and 52.4% of the hero patients had maintained secondary patency, however considering the design of the study with a small sample size, the fact that stents were placed for shorter lesions, lesions that were less likely to cross the thoracic outlet, wide variety of stents used and both interventions yielded similar results, one can infer that the getinge¿s icast¿ balloon expandable covered stents performed as expected.H3 other text : product not returned.

Event Description

N/a.

• Brand Name: ICAST COVERED STENT
• 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: 12725038
• MDR Text Key: 279241302
• Report Number: 3011175548-2021-01105
• Device Sequence Number: 1
• Product Code: JCT
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 10/30/2021
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention