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

Catalog Number	AB9U18060090
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
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
Pphysician attempted to implant an abre self-expanding stent with a 9fr sheath during treatment of a 40mm lesion in the patient¿s left proximal non-thrombotic iliac vein lesion (nivl).Vein diameter reported as 16mm.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.The thumbscrew/lock-pin was checked for securement prior to procedure and the thumbscrew/lock-pin was removed prior to attempted deployment.Embolic protection was not used.The vessel was pre and post dilated.The device was not passed through a previously deployed stent.It was reported the stent flowered perfectly.When physician was retracting the wheel, did not hear a clicking sound and the stent jumped forward a couple of mm, kind of fell off delivery system.The physician.Was pulling back the whole shaft while deploying and stent placement was adjusted after initial flowering.The stent deployed more distally than intended, groin access was being utilized.There was nothing unusual around the landing zone of the stent, there was stenosis at the confluence of ivc/civ.The stent was implanted, and procedure was completed.The delivery system was safely removed from patient.The stent jumping caused a portion of the stent to be partially extended in the ivc.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: the device delivery system was returned.The red locking pin was removed from the returned device.The size on the strain relief was 9f 18mm x 60mm.A kink was observed on the inner tubing.Approximately 4.5cm of the inner tubing was exposed.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: 19259183
• Report Number: 2183870-2024-00154
• Device Sequence Number: 2582372
• Product Code: QAN
• UDI-Device Identifier: 00643169796386
• UDI-Public: 00643169796386
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/15/2024

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 Expiration Date: 10/03/2025
• Device Catalogue Number: AB9U18060090
• Device Lot Number: B456796
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 07/13/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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 Sex: Female