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

Catalog Number	AB9U16150090
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
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 during a stent placement procedure using the abre stent for treatment of a fibrous, stenotic lesion identified in the left common and external iliac veins at a proximal location.The lesion exhibited stenosis greater than 60%, measured 120 cmin length, and the vein diameter was 14 mm, with minimal tortuosity and calcification.Patient abnormalities in relation to anatomy included stenosis due to post thrombotic syndrome.A 10 fr non medtronic sheath was used.Vessel was pre-dilated with a non medtronic device.The device did not pass through a previously deployed stent and no resistance was met during advancement. during deployment, difficulty was noted as the stent partially deployed into a wine glass shape, the thumb wheel stopped rolling back. the physician broke apart the handle with hemostats to manually pull the deployment string.String looked to be in a loop shape- heavy resistance in pulling string back (just like thumb wheel difficulty).Sheath was pulled back to try to reposition in hopes to ease deployment and troubleshooting.A few stronger pulls on the string and the stent deployed.Some stent cells appeared notably larger, while proximal cells appeared smaller and crunched down. the stent was ballooned at full length to address deployment irregularities.The stent was left implanted and was functioning properly with flow intact.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis visual inspection the device returned with the handle opened the stent was deployed on the returned device the clip was secure on the silver retractable sheath.The size on the strain relief was 9f 16mm x 150mm functional testing the blue isolation sheath and the silver retractable sheath were separated.The id of the blue isolation sheath was measured and a 0.108 inch pin was snug the od of the silver retractable sheath was measured and it measured 0.107 inches image analysis:two images and one video were provided for review.The images are single still shots from a computer monitor during venous intervention, and the video is a venogram obtained from a computer monitor, are are of fair quality.D.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: 23694956
• Report Number: 2183870-2025-00563
• Device Sequence Number: 15723991
• Product Code: QAN
• UDI-Device Identifier: 00643169796379
• UDI-Public: (01)00643169796379(17)280122(10)C029384
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AB9U16150090
• Device Lot Number: C029384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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
• Patient Sex: Male