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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263); Swelling/ Edema (4577)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Abstract reinterventions after stenting for chronic iliofemoral venous obstruction have an incidence of approximately 20% to 40% in the literature.The most common reason for this tends to be in-stent restenosis (isr).Although angioplasty historically has been the modality used to treat this problem, at times isr can be robust and associated with calcium deposits, leading to an inadequate outcome.Although newer debulking devices like the revcore can be helpful, sometimes even these devices are not adequate given their inability to secure a foothold on the fibrotic tissue to enable its removal.Using an intravascular lithotripsy catheter (12 mm) helps to soften the fibrotic tissue and fracture the calcium deposits, thus enabling angioplasty or a debulking device (if needed) to be successful.This case series outlines the author¿s experience with three patients with recalcitrant isr who benefited from using anintravascular lithotripsy catheter that enabled prolonged symptom improvement and stent patency over a follow-up of 19 months.However, the use of such a catheter for the treatment of venous isr represents an off-label use of the device.A 40-year-old african american woman with a history of hypothyroidism and migraines underwent right iliofemoral venous stenting for pain (vas pain score of 10/10) and swelling in the lower extremity (ceap clinical class 3 and vcss of 8).Stenting was carried out using a combination of an abre stent (medtronic, minneapolis, mn) cranially and a wallstent caudally for a diagnosis of multifocal nivl on ivus examination.After the procedure, she did well, with improvement of pain and swelling to the point they were no longer bothersome.However, approximately 18 months later, she developed a recurrence of the pain and swelling (vcss of 7).Dus examination revealed isr across the entirety of the stent with a maximum of 53% in the external iliac vein.She had been only on aspirin 81 mg, but was started on apixaban 2.5 mg twice daily and was scheduled for ivus confirmation of the diagnosis and stent reintervention.Technical aspects.Each patient was placed under general anesthesia in a supine position with preprocedural thromboprophylaxis in the form of enoxaparin (30 mg or 40 mg, based on body mass index) subcutaneously and bivalirudin (75 mg) intravenously.Access was obtained in the midthigh femoral vein under ultrasound guidance and an 11f access sheath was placed.A diagnostic ascending venogram was performed (fig 1).This demonstrated a reduction in the flow channel luminal area across the stentedsegmentinallthreepatients.Ivus interrogation (visions pv.035 digital ivus catheter, philips, amsterdam,thenetherlands) was thenperformedto confirm the diagnosis of stent malfunction.The presence of mild-to-severe isr across the stent column was noted with additional calcification noted in patient 1 (fig 2).Isodilation (angioplasty with a balloon equal to the rated diameter of the stent) was then carried out followed by hyperdilation (angioplasty with a balloon larger than the rated diameter of the stent) in each patient.Interval ivus interrogation was used to determine the extent of luminal gain.If an adequate flow channel was not restoredonivus examination(notedinallthreepatients), intravascular lithotripsy was used and focused on the areas of isr after angioplasty.To facilitate this, an 0.035¿ glide wire was switched outto an0.018¿ wire anda 12-mm lithotripsy balloon catheter was introduced to treat the previously determined areas.In total, 300 pulses were delivered in patients 1 and 2; only 210 pulses were used in patient 3 (fig 3).Ivus interrogation was again performed (fig 4) and repeat hyperdilation (fig 5) was carried out in areas where additional luminal gain was necessary.The goal was to secure a minimal luminal area of 125 mm2 , 150 mm2, and 200 mm2 in the stented common femoral, external iliac, andcommoniliac segments ,respectively.In all three patients, these flow channel luminal areas were attained on completion ivus interrogation at the end of the procedure.Completion venogram demonstrated good inflow, flow through the stent column, and outflow without any flow restrictions in all three patients (fig 6).The preprocedural antithrombotic regimen was restarted the evening of the procedure with all three patients disch arged on the day of the procedure with plans for continued long-term follow-up.No complications were notedeitherperiprocedurally or onsubsequentfollow-up visits.After the procedure.All three patients experienced symptom improvement after intervention, with the vcss improving from 9 to 4 in patient 1, from 7 to 4 in patient 2, and from 7 to 3 in patient 3.The stents were widely patent on dus in all three patients.These improvements were sustained over 19 months of followup.All patients will continue to with lifelong follow-ups with regular dus examinations alongside clinical visits.
Additional Manufacturer Narrative
Intravascular lithotripsy as a treatment option for recalcitrant in-stent restenosis in symptomatic patients with chronic iliofemoral venous obstruction 2025 the author(s).Published by elsevier inc.On behalf of society for vascular surgery.This is an open access article under the cc by-nc-nd license (http://creativecommons.Org/licenses/by-nc-nd/4.0/).Https://doi.Org/10.1016/j.Jvscit.2025.101921 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: 24739653
• Report Number: 2183870-2026-00144
• Device Sequence Number: 19951960
• Product Code: QAN
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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
• 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: 03/06/2026
• Initial Report FDA Received Date: 03/31/2026
• 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; Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Race: Black Or African American