MAUDE Adverse Event Report: COVIDIEN ABRE VENOUS SELF-EXPANDING STENT SYSTEM; STENT, ILIAC VEIN

Catalog Number	AB9U14100090
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a physician placed a 14x100mm abre stent to treat a right common iliac vein stenosis as part of a pulmonary embolism thrombectomy and the stent migrated the following morning.Minimal vessel tortuosity was reported.The vessel was not pre-dilated.The vessel was post-dilated.The patient clinical presentation at the time of implant was pulmonary embolism (pe).The lesion location and location of stent placement was the external iliac vein (eiv).The patient was hydrated prior to procedure.An angiogram was used for imaging, and the degree of stenosis was >50%.The stent did not land in a curve.The stent was confirmed to have proper placement following deployment.The stent migrated to the heart.The stent was explanted from the heart, ilac left alone.The patient required prolongation of existing hospitalization.
Additional Manufacturer Narrative
Additional information: physician did not use intravascular ultrasound (ivus) to get any measurements.Patient came in with a pulmonary embolism and they had difficulty getting access through the right iliac vein and stented it based on the angiogram.They do not think it was thrombus in the iliac but cannot be sure.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Image review image 1 still image of a chest x-ray, is a still image of the thoracic cavity showing a stent appearing to be in the heart, image 2 is a fluoroscopic image of a stent placed in the right internal iliac vein to the right common iliac vein, image 3 is a subtracted image of a stent placed in the right internal iliac vein to the right common iliac vein.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ABRE VENOUS SELF-EXPANDING STENT SYSTEM
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24209646
• Report Number: 2183870-2026-00046
• Device Sequence Number: 5431284
• Product Code: QAN
• UDI-Device Identifier: 00643169796300
• UDI-Public: (01)00643169796300(17)280320(10)C067253
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AB9U14100090
• Device Lot Number: C067253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 04/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/25/2026; 04/27/2026
• Date Device Manufactured: 03/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 109 KG