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

Catalog Number	AB9U14150090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient received three abre iliac vein stents on (b)(6) 2025 for may thurner syndrome.The patient has no prior history of deep vein thrombosis and was on anticoagulation therapy after the procedure.On (b)(6) 2025 the patient was prescribed tranexamic acid as needed for menses but was not in use during any stent restenosis events.Months later, the patient reduced the eliquis dosage to begin a supervised wean.Follow-up imaging showed more than 50% narrowing inside the stents in multiple segments.The patient had balloon angioplasty to open all narrowed segments.Two months later the patient had a second angioplasty because the narrowing returned despite ongoing therapeutic anticoagulation.During that procedure, a localized steroid treatment device was also used.Despite these interventions and anticoagulation, the patient developed additional in-stent restenosis.The patients physician noted that each recurrence of restenosis consists of blood material buildup rather than scar tissue.A hematology evaluation did not identify any underlying clotting disorder or hematologic cause for the recurrent in-stent restenosis.Concomitant medical products and other treatments include aspirin 81mg, cetirizine, eliquis (apixaban) 5mg twice daily, epinephrine auto-injector (as needed), famotidine (as needed), iron supplement (3 times weekly), meloxicam (as needed), midodrine (as needed), multivitamin, nebivolol, vitamin c, vitamin d.Th e patient is still on anticoagulation therapy, and further procedures are being planned.
Additional Manufacturer Narrative
Continuation of d10: product type: 0673-peripheral stent; implant date: (b)(6) 2025; explant date ; product id ab9u14080090 (b794765); product type: 0673-peripheral stent; implant date: (b)(6) 2025; explant date 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 ; +353(091)708096
• MDR Report Key: 50207312
• Report Number: 2183870-2026-00376
• Device Sequence Number: 10274612
• Product Code: QAN
• UDI-Device Identifier: 00643169796324
• UDI-Public: (01)00643169796324(17)271017(10)B804805
• Combination Product (Y/N): N
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AB9U14150090
• Device Lot Number: B804805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 10/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRODUCT ID AB9U12120090 (B532105),
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 115 LB
• Patient Race: White