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

Model Number	AB9U14080090
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician was using an abre self-expanding stent for the treatment of a 50mm lesion with 75% stenosis in the proximal region of the left common iliac vein.The artery diameter was 12mm with mild tortuosity and no calcification.A 9fr non medtronic sheath and a 0.035 stiff glidewire was used.The device was prepped as per the ifu with no issues identified.The lesion was not pre-dilated.There was no resistance during advancement and the device did not pass through a previously deployed stent.The patient¿s clinical presentation at the time of implant was nivl.It was reported the physician used ivus to ensure the correct sized stent was used.The healthy left common iliac vein was measuring 12mm on ivus so the physician decided to use a 14mm x 80mm abre stent based on the abre ifu.The stent placement location was the left common iliac vein.Physician mentioned that the thumbwheel stuck a little bit at the start of deployment, but then it worked fine after 2 clicks of the thumbwheel and the stent deployed with no issues.It was also mentioned that the inner shaft of the delivery catheter "stuck" to the stent during removal of the delivery catheter.After a minute or t wo, the delivery catheter was successfully detached from the stent, and it was mentioned that no movement, or change in position, of the stent at that time was noticed, the physician confirmed proper placement following deployment.The stent did not land in a curve.Physician decided to not post-dilate the stent after deployment and finished the case with no issues.The patient did not receive any fluids prior to the procedure, it was reported that providing fluids to the patient prior to the procedure is not a standard practice for this physician group.Patient was in pacu recovering when the patient started to complain of chest pain and shortness of breath.The staff ran an ekg and noticed that there was a foreign device stuck in between the right atrium and right ventricle, which was confirmed to be the abre stent that was deployed just hours before.Patient was immediately sent to ir department to retrieve the migrated stent, which was done successfully with no further incident to the patient.
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.
Additional Manufacturer Narrative
Image analysis the image provided and labeled ¿post stent venogram¿ shows a significant portion of the stent extends into the ivc, and is not apposed to the vessel wall.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.
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.

• 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: 16982765
• Report Number: 2183870-2023-00180
• Device Sequence Number: 6853001
• Product Code: QAN
• UDI-Device Identifier: 00643169796294
• UDI-Public: 00643169796294
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2023

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: 05/05/2025
• Device Model Number: AB9U14080090
• Device Catalogue Number: AB9U14080090
• Device Lot Number: B380630
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 07/14/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/06/2023; 07/24/2023
• Date Device Manufactured: 05/06/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0464-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female