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

Model Number AB9U16100090

Device Problem Difficult to Advance (2920)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use an abre self-expanding stent during procedure to treat a none calcified lesion with no plaque or fibrous with 87% stenosis.The vessel was little tortuous.During index procedure, a 16x100 abre stent was implanted.The lesion was predilated.A resistance was encountered when advancing the device with no force used.Thrombus noted post stent implantation.Two weeks post index procedure, patient came in for a thrombectomy, but have images were taken and physician notices that thrombus had cleared up.Thrombus cleared prior to second procedure.Angiography on proposed date of thrombectomy did not show the stent compressed/deformed but did notice compression to the eiv and a second stent was deployed.Second stent was successfully implanted.There was no further patient injury.

Manufacturer Narrative

The abre self-expanding stent was not returned for evaluation.No ancillary devices or images were returned for review.The device is not expected to return as it remains in the patient.The customer experience of ¿resistance encountered¿ could not be confirmed.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
• Type of Device: 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12923231
• MDR Text Key: 281657636
• Report Number: 2183870-2021-00439
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00643169796355
• UDI-Public: 00643169796355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AB9U16100090
• Device Catalogue Number: AB9U16100090
• Device Lot Number: B273549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2022
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 98 KG