MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; ILIAC COVERED STENT, ARTERIAL

Device Problems Nonstandard Device (1420); Device Dislodged or Dislocated (2923)

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

Event Date 07/23/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 routine transluminal angioplasty.Failure of atrium icast sheath: dislodgement of stent.Resulting in "transperitoneal open exposure" of the superior mesenteric artery to retrieve stent.Then retrograde with gore vbx stent.Which occluded after 5 months.On (b)(6) 2022 underwent ilio-mesenteric arterial bypass using graft.Recall # z-1077-2022, event: (b)(6), status: ongoing.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION
• MDR Report Key: 16733003
• MDR Text Key: 313330312
• Report Number: MW5116608
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 MG; BRILINTA 60 MG; FEROSUL FERROUS SULFATE 65 MG ; ROSUVASTATIN 20 MG
• Patient Outcome(s): Required Intervention; Disability; Other; Hospitalization; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White