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

Model Number AB9U16150090

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2022

Event Type  Injury  

Event Description

Patient presented with venous stasis, swelling and non-healing venous leg ulcers.Diagnosed with symptomatic non-thrombotic iliac vein lesion of right eiv, ceap 6.An abre self-expanding stent was implanted in the right external iliac vein (overlying right internal iliac artery compression).The patient was hydrated.Ivus was used for vessel sizing.Physician measured the eiv to be roughly 12-14 and civ to be roughly 15mm, and elected a 16mm diameter stent in eiv.While the patient was of large body habitus, the physician did not want to use an 18mm diameter stent because he thought the oversizing would have been extreme and would lead to patient pain.Physician stated he would elect the same size stent if they did the procedure again.Ivus was used throughout index procedure.Focal 95% area stenosis confirmed on ivus.Ivus used post procedure to confirm stent placement.The stent did not land in a curve.The stent covered the full area of stenosis.There was normal delivery of the stent.Everything looked great at time of deployment.The patient was being seen in wound care clinic weekly prior to and following stent placement.Approximately 3 months post procedure the patient developed new leg edema and dus was carried out.Dus was negative for deep vein thrombosis (dvt) and the stent was patent.Patient continued to have edema and wound healing stalled.Approximately 4 months post procedure repeated dus reported roughly 75% in-stent stenosis with flow channel narrowing without dvt.Stent remained in place at this time.Physician scheduled ivus and venogram with potential for intervention but this was delayed.The patient then contracted covid and procedure was delayed further.Approximately 5 months post implant ivus and venogram showed stent had migrated (traversed right atrium and embedded into svc with caudal end in ivc).Patient did not have shortness of breath.Presented with recurrent leg symptoms.The vein appeared to be of normal caliber at this time with some fibrosis/calcification visible.The patient noted that leg symptoms felt much better between the 2nd and 3rd dus.The stent was retrieved 2 days post dus with robotic cardiothoracic surgery.The stent was removed easily from ivc but had to be cut in half in order for svs removal.The patient is doing well.The physician commented that the patient¿s complex history with covid and likelihood of going off coumadin prior to the ivus and venogram may have contributed to the stent thrombosing creating distal venous pressure causing the stent to embolize (similar to the pressure that will build up behind an ivc filter).There was no further patient injury reported.

Manufacturer Narrative

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

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.

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
• 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: 13590035
• MDR Text Key: 286047569
• Report Number: 2183870-2022-00062
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2022

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
• Device Operator: Health Professional
• Device Model Number: AB9U16150090
• Device Lot Number: B227177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 04/26/2022; 10/11/2022
• Supplement Dates FDA Received: 04/27/2022; 10/12/2022
• Date Device Manufactured: 06/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0464-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 129 KG