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

Model Number AB9U16150090

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician attempted to use an abre self expanding stent with a non-medtronic 13f (inari) sheath and non-medtronic (bsc amplatz super stiff) guidewire during treatment of a 250mm cto (chronic total occlusion-100%) in the patient's left common and external iliac veins.Artery diameter reported as 14mm.Slight vessel tortuosity reported.There was no  damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The device was prepped per ifu with no issues identified.  prior to stent placement the patient necessitated thrombectomy with a non-medtronic (inari) clottriever and flowtriever.Utilization of a non-medtronic (boston scientific angiojet) atherectomy device was also employed.All veins were serially predilated from 12mm-14mm with appropriate angioplasty balloons. the device was not passed through a previously deployed stent. the stent system was advanced across the lesion via popliteal vein access without issue. no resistance was encountered during advancement.The thumbscrew/lock-pin was checked for securement prior to procedure. the lock pin was removed just prior to stent deployment with much difficulty. the lock pin could not be removed with bare hands upon multiple unsuccessful attempts to remove and had to employ the utilization of hemostats to remove. the decision was made to proceed with using the stent in spite of this issue.  stent deformation occurred in vivo during positioning/deployment is reported.Deployment of the stent was began at the confluence of the inferior vena cava/left common iliac vein.The first cell group on the abre stent deployed without issue as the physician used the thumb wheel toexpose the stent.The second cell group of the stent began to give the appearance that backwards tension was being applied to the stent delivery system, even though this was observed and verified to not be the case.The irregularity of the stent was observed throughout the stent deployment process until approximately the last 20mm of the stent.Decision was immediately made to place an additional 16mm diameter stent inside the maldeployed stent to tent up the portions of the prior mal-deployed stent.This deployment was undertaken without issue.No further injury reported.

Manufacturer Narrative

Additional information: no forward or backward tension applied to the stent system after initial flowering.The stent did appear to elongate.It was a 16x150mm and after deployment, it exceeded the marks made on the screen during the ivus measurements.Contrast extravasation was noted on final venogram images.However, there is no way to determine if it was caused by the stent in question, multiple, pre-stent passes with the inari devices, or balloon dilations.Patient is alive and well according to the most recent conversation with the radiologist.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.

Manufacturer Narrative

Additional information: one image was provided for evaluation.In the image the stent appears to be deformed.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
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13153514
• MDR Text Key: 288524000
• Report Number: 2183870-2022-00006
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00643169796379
• UDI-Public: 00643169796379
• 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,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB9U16150090
• Device Catalogue Number: AB9U16150090
• Device Lot Number: B249767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Date Device Manufactured: 08/13/2021
• 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 Sex: Male