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

Model Number	AB9U16150090
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use an abre self-expanding stent along with a 9fr sheath and wholey guidewire during procedure to treat a none calcified fibrous lesion in the left proximal confluence of common iliac vein with greater than 50% stenosis.The vessel was moderately tortuous.No embolic protection was used.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.Stent deformed in vivo during positioning/deployment occurred.Physician completed the procedure.A 6mm x 40mm evercross pta was used to dilate the stent distal edge.The length of deployed stent in vessel was 150mm.A non-medtronic 14mm x40 device was used to pre dilate.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.It was reported that the distal edge of the stent appeared compressed at the first few mm of the stent deployment.The remainder of the stent deployed successfully.The physician utilized a 6x40 evercross to post dilated the compressed distal edge of stent.The balloon tracked easily and upon a few atmospheres of pressure the distal edge of the stent popped open and looked as it usually does when deployed.The physician used a 14x40 non-medtronic to post dilated and then ivus the stent.Good apposition was observed and the case was completed.Physician reported the femoral vein and greater saphenous vein had a lot of collateral due to chronic clot.No patient injury reported.

• 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: 14786104
• Report Number: 2183870-2022-00215
• Device Sequence Number: 5935554
• Product Code: QAN
• UDI-Device Identifier: 00643169796379
• UDI-Public: 00643169796379
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2022

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: 10/29/2023
• Device Model Number: AB9U16150090
• Device Catalogue Number: AB9U16150090
• Device Lot Number: B109681
• 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: 06/08/2022
• Initial Report FDA Received Date: 06/23/2022
• Date Device Manufactured: 10/29/2020
• 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: Unknown