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

Model Number AB9U16080090

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2022

Event Type  Injury  

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.

Event Description

A physician implanted an abre self-expanding stent for the treatment of a fibrous lesion with chronic total occlusion in the distal region of the superior vena cava (svc).There were no issues noted when removing the device from the hoop/tray.There was mild tortuosity and severe calcification.The device was prepped as per the ifu with no issues identified.The procedure began with access through left sided port.They passed a non-medtronic wire (amplatz) wire easily through the stenosis in the svc after placing a 9fr sheath.The physician predilated the ends of the stenosis with a non-medtronic 16fr (atlas) balloon, however, didn't predilate the actual compression point as they didn't want to predilate the tight compression with concerns the stent would then watermelon seed forward and we would lose accuracy.They had a 12 and 16 non-medtronic balloons (atlas) in the room to post dilate after stent deployment.Post deployment when attempting to walk the delivery system off the wire, difficulties removing the device were encountered and the nose cone of the stent was stuck beyond the tight compression.They unknowingly pulled the system out, but the nose cone and shaft were left behind in the body with the shaft extending out of the sheath.The stent has caught upon the stent during withdrawal.They then attempted to pass an 018 from the neck, however it couldn't pass.We then got femoral access to attempt to snare the nosecone from the bottom.We were eventually successful.A 018 wire was put down the shaft/nosecone of the foreign body in order to preserve access through the stent.Once the foreign body was removed, a non-medtronic balloon (035 quick cross) was used and then were able to post dilate the stent to the correct size and the subsequent venogram was perfect.No resistance was not encountered when advancing the device excessive force used, the device pass through a previously-deployed stent.No further patient injury reported for this event.

Manufacturer Narrative

Image analysis images were provided for evaluation.In the images you can see the delivery catheter post deployment.The nose cone and shaft were u unattached.In the final image you can see they have retrieved the nose cone and distal shaft.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: 15834191
• MDR Text Key: 304012796
• Report Number: 2183870-2022-00394
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00643169796348
• UDI-Public: 00643169796348
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• 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: B432975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Date Device Manufactured: 08/17/2022
• 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 Age: 32 YR
• Patient Sex: Female