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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Arrhythmia (1721); Chest Pain (1776); Insufficient Information (4580)

Event Date 05/19/2022

Event Type  Injury  

Event Description

It was reported that a physician was attempting to use a abre self-expanding stent to treat a lesion in a patient.The lumen flushed prior to use and the device was prepped as per ifu.It was reported that the patient's proximal/distal measurements in healthy tissue had measured 18mm.The physician pre-dilated with 10mm balloon and the patient experienced extreme back pain.The physician decided to go with a 14mm stent.No issues until patient went to emergency room with chest pain and palpitations.The stent migrated to upper ivc/superior portion of right atrium.Treatment was required; to remove the stent, they first tried inflating 14mm balloon to drag the stent back from the atrium.This was unsuccessful so they tried using a gooseneck snare which did not work either.They then tried a 16mm balloon which did not work.They were able to pull it out through a 7fr sheath using the snares used to retrieve ivc filters.No further patient injury was reported for this event.

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

Additional information received reported that the patient presented with lower extremity swelling and pain causing significant impact on qol (¿quality of life¿).No clinical hx of dvt and no prior intervention (including superficial venous treatment).A nivl was confirmed on ivus with 61% stenosis and vein scarring noted.Lesion location and location of stent placement civ to cfv.Patient was hydrated.The physician measures the vein for reference diameter in ipsilateral vein proximal and distal to the lesion.The physician undersized this stent since the patient had significant pain with pre-dilation.Ipsilateral ivus measurements - cfv 10.6-13.6, eiv 12.0-15.4, civ 12.4-18.9.The physician typically uses ivus and determines treated when there is >60% stenosis without wounds and >50% stenosis with wounds.The physician measured 61-65% stenosis on ivus with vein ¿scarred¿ in area of stenosis.Pre-dil with 10mm balloon (patient experienced backpain ¿ this dictated the size of stent because the physician was worried about patient pain); post-dilation of the 14x120 stent was performed with a 12x60 mm balloon.Nothing unusual noted during delivery of the stent, no excessive force used.Plavix 75mg/day for 3 months was given.Ultrasound planned in 1-2 weeks.The leg edema and pain resolved within 3 mos.The patient had presented to the er with palpitations and chest pain and cta demonstrated the stent bridging the ivc to the ra.Stent migrated to upper ivc/ superior portion of right atrium with alleged onset of symptoms one week prior.Stent was removed within 24 hours of presented to hospital.Physician tried multiple attempts with balloon (14mm and then 16mm dimeter) and gooseneck snare to retrieve stent by dragging back from atrium unsuccessfully.Ir was able to use ivc filter snare to pull stent into 7fr sheath and remove safely.The patient is alive and continues to do well.Implanting physician also noted that he re-evaluated her compression and it is no longer be present.Physician performed a duplex us following stent retrieval and noted the reflux in the cfv and popliteal was gone.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: 14618551
• MDR Text Key: 293446195
• Report Number: 2183870-2022-00196
• 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
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• 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: 37 YR
• Patient Sex: Female