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

Catalog Number	AB9U14080090
Medical Device Problem Codes	Premature Activation (1484); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image analysis image one is of the shipping carton.Lot number c062836 was observed on the label on the shipping carton and is consistent with the lot number provided in gch.Image two is of the device inside a bag.The red locking pin is still in place; the stent is observed to be deployed inside the sheath.Image three is a cine image.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 procedure involving the abre self expanding stent along with a 9fr non-medtronic sheath, the device was deployed in the left distal common iliac vein (peripheral vein).The abre stent was put through 9fr sheath and stent was already deploying even with safety pin in place.The stent detached in vivo and required a surgical cut-down intervention to remove the detached stent.The patient's common femoral vein tore after stent deployed and was removed.The patient was admitted to the hospital, and the procedure was aborted.The device was explanted.
Additional Manufacturer Narrative
Product analysis the device returned with the red locking pin still securely in the handle the size on the strain relief 9f 14mm x 18mm the distal section of the catheter was loaded in an unknown 9f introducer the stent was deployed but remained fixed to the introducer kinks were observed on the introducer biologics were observed on the silver isolation sheath and a kink was noted on the silver sheath and on the inner tubing biologics were observed on the stent and the stent was deformed.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: 22150582
• Report Number: 2183870-2025-00285
• Device Sequence Number: 7812261
• Product Code: QAN
• UDI-Device Identifier: 00643169796294
• UDI-Public: (01)00643169796294(17)280313(10)C062836
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 08/15/2025

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: AB9U14080090
• Device Lot Number: C062836
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male