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

Model Number AB9U16080090

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 11/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician implanted abre self-expanding stent during procedure to treat none calcified lesion in the left common iliac vein.A 10fr sheath was used during the procedure.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.The lesion was pre dilated with a 14x60 balloon.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.It was reported that the stent was originally implanted in the left common iliac vein but migrated to ra.The migrated stent was removed with a snare 3 days post implant.A new stent was implanted in the common iliac vein to external iliac vein.The vessel was post dilated with 16mm balloon and ivus.There was no further patient injury reported.

Manufacturer Narrative

Additional information: the stent was safely removed from the patient.According to physician, the patient is discharged and home.Lot number provided.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: the stent was reported to have migrated to the right atrium.There was no vessel damage.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: ivus was used for sizing.The physician sized the vessel at a 14mm, so chose the 16x80.The physician stated that he usually chooses a longer stent, but this was a very focal, ostial lesion so he decided shorter.Post-deployment ivus showed the stent to be opposed to the vessel throughout the stent.Ivus sizing method which includes the proximal vein diameter, the distal vein diameter, and using the area as well (in this case there was pre-stenotic dilatation).They also measured the more distal iliac vein where more normal sized.Predilation was completed with 14 and postdilution with 16.Iliac vein compression was 68% by ivus (64 mmsq at compression site (ostial iliac) and reference site 202 mmsq) the left common and external iliac vein size was determined.The physician thinks the patient may not have been adequately hydrated.The practice does follow a standard protocol for hydration and patient was prehydrated per routine 75cc/hr.Landing zone was in post stenotic dilatation.Migrated to right atrium (ra).The stent did extend into the cava for a very short distance which he thinks may have contributed to the migration.Patient called office with chest pain with inspiration and brought in immediately, diagnosis made with chest x ray and immediately taken to the cath lab.The physician consider placing that stent back into the iliac and extending with a new one, but felt the stent was damaged by the snares so removed it.An 18x150 stent was used during the same procedure and he was pleased with the results.The patient is doing well.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.

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

Image review: six images in total were provided for evaluation.Images one and two shows the stent implanted.Images three to six show a snare been used to remove the stent.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: medtronic received a literature article published on the case 'iliac venous stent embolization to the right atrium and subsequent extraction with in vivo recrimping', containing the following additional information.The patient had prior high-risk pulmonary embolism treated with catheter-directed thrombolysis and residual leg edema residual leg edema was found to have severe extrinsic compression of the left common iliac vein (civ) by the right common iliac artery on ultrasound.Venography and intravascular ultrasound (ivus) suggested iliac vein compression syndrome (may-thurner).Ivus demonstrated reference vessel diameter 18.9 mm, proximal civ compression of 68% (>50% considered significant), and minimum lumen area 64 mm2.The vessel was postdilated with a 16-mm non-medtronic xxl balloon at 4 atm.Two days post procedure, the patient reported acute-onset dyspnea, palpitations, and pleuritic chest pain.Chest x-ray demonstrated stent embolization to the right atrium.Transthoracic echocardiogram showed a mobile stent at the inferior vena cava junction extending into the right atrium and abutting the interatrial septum.Endovascular retrieval with surgical backup was planned.Left femoral vein access was obtained with a 26f non-medtronic sheath.An 0.03500 j-wire was advanced through an angled glide catheter coaxially through the stent.A 16-mm xxl balloon was advanced over the wire, coaxially within the stent, and inflated to 4 atm.Two non-medtronic en snares (30 mm, 25 mm)) were introduced through the same sheath, over the back of the balloon, and used to ¿recrimp¿ the stent onto the balloon.The stent and inflated balloon were retracted into the left civ.Following balloon removal, the stent was pulled into and through the sheath with the snares.The left civ was stented with an 18x150 mm abre stent postdilated with an 18-mm xxl balloon at 4 atm to ensure adequate oversizing, confirmed by ivus.Postprocedural transthoracic echocardiogram showed no significant valvular abnormalities and no pericardial effusion.The patient was discharged on rivaroxaban and clopidogrel.Follow-up ultrasound showed a patent left iliac vein stent.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: 12859125
• MDR Text Key: 281134269
• Report Number: 2183870-2021-00421
• Device Sequence Number: 1
• Product Code: QAN
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB9U16080090
• Device Catalogue Number: AB9U16080090
• Device Lot Number: B273034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Date Device Manufactured: 09/28/2021
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 109 KG