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

Model Number	AB9U14150090
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
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 abre self-expanding stent along with non-medtronic 11 fr sheath and 0.035" glidewire during procedure to treat a moderately calcified fibrous lesion in the left distal common femoral vein (cfv).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 deformation occurred in vivo post deployment.It was reported that a non-medtronic 16x6x80 pta with manual aspiration.Post dilatation may not have been fully deflated and got caught on end of caudal stent.Balloon did not pop and was safely removed with stent in place.The 14x150 abre stent was deformed by the non-medtronic balloon.Balloon dilated deformed stent and realigned deformed 14x150 with a 16x120 abre stent.16x120 abre stent was implanted to treat the deformed stent.No issues reported post dilation of this stent.The vessel was pre dilated with a 16x5x80 pta balloon.The device passed through a previously deployed stent.There was no resistance encountered when advancing the device.No patient injury was reported.
Additional Manufacturer Narrative
Image analysis: three images were returned for evaluation.In the first image you can see the balloon inside the stent and the stent been fully deployed.In the second image you can see a wire inside the stent and the stent appears to be deformed.The third image is unclear.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.

• 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: 13568709
• Report Number: 2183870-2022-00056
• Device Sequence Number: 5951192
• Product Code: QAN
• UDI-Device Identifier: 00643169796324
• UDI-Public: 00643169796324
• 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: 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,Followup
• Report Date (Section B): 05/12/2022

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 Expiration Date: 07/05/2024
• Device Model Number: AB9U14150090
• Device Catalogue Number: AB9U14150090
• Device Lot Number: B230011
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 05/12/2022
• Date Device Manufactured: 07/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female