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

Catalog Number	AB9U20150090
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
A physician was attempting to implant an abre stent for treatment of a fibrous lesion with 70% stenosis in the left common iliac vein and external iliac vein.There was severe tortuosity and no calcification.A 10 fr non medtronic sheath and a 0.035 non medtronic guidewire were used.The device was prepped as per the ifu with no issues identified.The lesion was pre-dilated with a 16mm x 40mmpre-dilation device.It was reported the 1st stent was inserted and positioned in common iliac vein, external iliac vein.Resistance had been encountered during advancement to the lesion.The device had not passed through a previously deployed stent.Lock pin was removed and physician began deployment using thumbwheel, stent should begin flowering around 9 clicks but the stent was not exposing out of stent catheter at 20 clicks and the stent catheter was removed and stent began deploying as it approached the sheath to be removed.This caused significant resistance, distal or leading end of the stent inverted and broke.The stent did not fully detach until within the sheath.Stent catheter, sheath, stent was removed from patient.No part of the stent was left inside the patient. access was performed and another 10fr sheath inserted.Another abre 20mm x 150mm was opened.  a stiffer wire was used to provide additional support for delivery, resistance was met again during advancement.Once the stent catheter was in position, lock pin was re moved and thumbwheel was activated.Again, stent was not deploying after more than 15 clicks of thumbwheel, stent catheter was pulled back and again deployed when outside of sheath.Procedure was aborted with no injury to the patient or any part of either stent left inside the patient.
Additional Manufacturer Narrative
Product analysis visual inspection: red locking pin was removed from the returned device the stent was deployed inside the introducer it was not possible to remove the stent out of the introducer due to the damage to the stent.No detachment was observed to 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.

• Brand Name: ABRE VENOUS SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 17959018
• Report Number: 2183870-2023-00381
• Device Sequence Number: 12514322
• Product Code: QAN
• UDI-Device Identifier: 00643169796478
• UDI-Public: 00643169796478
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2025
• Device Catalogue Number: AB9U20150090
• Device Lot Number: B417716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 100 KG