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

Model Number	AB9U18100090
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use the abre self expanding stent during procedure to treat soft tissue lesion in the distal left common iliac vein.There was no calcification.The vessel had moderate tortuosity and exhibited 60% stenosis.The artery diameter was 16mm and lesion length was 80mm.A 9fr sheath and non medtronic guidewire were used.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.It was reported there were deployment issues with partial deployment.The stent wheel broke after 4 to 6 clicks during deployment.The thumbscrew was checked for securement prior to procedure and the lock-pin was removed prior to deploying.The lesion was pre-dilated with a non medtronic 18mm device.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.The stent was partially deployed at target site.Stent struts were exposed in the patient during deployment attempt.Struts were exposed during removal.No vessel damage was noted.The device was safely removed from the patient.The stent was pulled out with the sheath through the vein.No intervention was required for removal.The procedure was completed by removing the partially deployed stent and a 11fr sheath was inserted into the patient and a new stent was used.No patient injury.
Additional Manufacturer Narrative
Product analysis: the abre self-expanding stent was returned to medtronic investigation lab for evaluation.The device was returned coiled inside 2 biohazard bags.The stent was partially deployed.Kink observed on outer sheath.Approximately 60mm of the inner tubing was exposed.Due to the thumb wheel wire been broken the remainder of the stent could not be deployed.Stent could not be fully deployed.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.

• 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: 12959073
• Report Number: 2183870-2021-00442
• Device Sequence Number: 1751616
• Product Code: QAN
• UDI-Device Identifier: 00643169796409
• UDI-Public: 00643169796409
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: 03/17/2024
• Device Model Number: AB9U18100090
• Device Catalogue Number: AB9U18100090
• Device Lot Number: B177372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 03/05/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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