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

Device Problem Insufficient Information (3190)

Patient Problems Respiratory Failure (2484); Thrombosis/Thrombus (4440); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received an article: karkkainen, j.E.(2020).Outcomes of small renal artery targets in patient treated by fenestrated-branched endovascular aortic repair.European journal of endovascular surgery, 910-917.Purpose: to evaluate renal related outcomes in patients who had incorporation of a small renal artery (ra) during fenestrated-branched endovascular aortic repair (f-evar).Method: a total of 215 consecutive patients enrolled in a prospective f-bevar trial were reviewed.Conclusion: incorporation of <4.0 mm ras during f-bevar is associated with lower technical success, higher risk of arterial disruption and kidney loss, and lower patency rates at one year.Per the article adverse events included rupture, kidney loss, endoleaks, thromboembolic events, respiratory failure and bowel ischemia.

Manufacturer Narrative

Article reviewed: karkkainen et al.2020.Outcomes of small renal artery targets in patients treated by fenestrated branched endovascular aortic repair.Eur j endovasc surg; 59:910-917.The subject article is a subset analysis of an on-going non-randomized single center fenestrated-branched endovascular aortic repair (f-bevar) trail of 215 consecutive patients recruited between 2014 and 2017.The purpose of the study was to evaluate renal related outcomes in patients who had incorporation of a small (<4.0 mm) renal artery (ra) during fenestrated-branched endovascular aortic repair (f-bevar).This complaint is based on information found within a article/literature review.There was no product that was available for evaluation, therefore a device evaluation could not be conducted and the complaint cannot be confirmed.The author of the article did not report any major adverse patient effects as result of this event.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.The hazardous situation/harm is addressed in the risk file and is operating within its risk profile.There was no evidence within the article that the device was the cause of the reported event.The complaint history review did not identify an adverse trend, therefore no escalation to capa process is required.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.The instructions for use clearly states that potential adverse effects of advanta v12 balloon-expandable stent include, but may be not limited to: inadequate implantation or intimal trauma, restenosis of stented lesion, stent misplacement, migration or deformation, systemic embolization or thromboembolic episodes.Although 29 patients (17%) had major adverse events, four target vessels with ruptures were approached through fenestrations, three of the four patients with ra rupture developed acute kidney injury postoperatively and one patient with ra rupture died two months after the procedure from an unknown cause, however considering the design of the study, no deaths within 30 days, no difference between the groups in occurrence of major adverse effects and the fact that incorporation of smaller then 4.0 mm in diameter ras during f-bevar is technically feasible (92% technical success) but is associated with a significant risk of ra rupture and kidney loss, one can infer that the getinge¿s icast¿ balloon expandable covered stents performed as expected.H3 other text : product not returned.

• 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: 11513792
• MDR Text Key: 240586854
• Report Number: 3011175548-2021-00304
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• 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
• Date Manufacturer Received: 10/19/2022
• 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