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

Catalog Number	AB9U12100090
Medical Device Problem Codes	Malposition of Device (2616); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2024
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
A physician was attempting to use an abre stent for treatment of a lesion in the mid right great saphenous vein (gsv).There was minimal tortuosity and calcification.A 10cm 10fr non-medtronic sheath and a 260cm 0.035" non-medtronic guidewire were used.The ifu was followed.The device passed through a previously deployed abre stent.Severe resistance was encountered during advancement.It was reported the device would not advance into desired deployment location.When attempting to remove from the patient, the stent deployed unintentionally outside of the target site prior to removal from the sheath.The stent deployed more distally than intended and remains in the patient.There was nothing unusual around the landing zone of the stent.No injury or intervention as a result.The delivery system was safely removed.A 14x60 protege gps stent was used to complete the treatment of the lesion.5 minute delay due to product malfunction.No patient injury reported.
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.

• 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: 20703895
• Report Number: 2183870-2024-00410
• Device Sequence Number: 15537307
• Product Code: QAN
• UDI-Device Identifier: 00643169796249
• UDI-Public: 00643169796249
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/27/2025

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: AB9U12100090
• Device Lot Number: B756044
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/27/2025
• Date Device Manufactured: 07/08/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Male