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

Catalog Number	AB9U12120090
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
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 patient underwent treatment for a lesion in the left mid and distal common and external iliac vein using a 12x120mm abre stent.The lesion exhibited 90% stenosis over an 80mm length, with a vessel diameter of approximately 10mm.Minimal vessel tortuosity and minimal vessel calcification was reported.There were abnormalities in relation to anatomy, with tumor compression of left common and external iliac vein reported.A 10fr non-medtronic sheath was used.The vessel was pre-dilated with a 12x40mm non-medtronic pta dilatation catheter.Physician crossed lesion easily despite compression.The abre stent was placed across lesion without delivery issues.After placement, severe compression and deformation of the distal segment of the stent were observed, including pancaking and incomplete opening, as confirmed by intravascular ultrasound and venography, which also showed delayed contrast washout indicating flow-limiting compression.The vessel was post-dilated with 12x40mm non-medtronic pta dilatation catheter, then just the distal portion of stent was post dilated with a 14x40 non-medtronic pta dilatation catheter, but severe compression persisted.The compressed segment was relined with a non-medtronic balloon-expandable stent graft to provide greater radial force, resulting in improved final outcome without patient impact.
Additional Manufacturer Narrative
Image analysis: one image was provided for evaluation.In the image you can see the stent does not appear to have fully expanded.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: 24161304
• Report Number: 2183870-2026-00032
• Device Sequence Number: 9112819
• Product Code: QAN
• UDI-Device Identifier: 00643169796256
• UDI-Public: (01)00643169796256(17)280921(10)C186168
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 04/03/2026

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: AB9U12120090
• Device Lot Number: C186168
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 09/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 67 KG