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

Model Number	AB9U16150090
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use the abre venous self expanding stent during procedure to treat non calcified soft tissue lesion in the distal right femoral vein.The vessel had little tortuosity and exhibited 70% stenosis.The artery diameter was 14mm and lesion length was 150mm.A non medtronic 10 fr sheath and 0.035'' guidewire were used.There was no damage noted to packaging and no issues when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.It was reported that there were deployment/partial deployment issues.There was no damage to deployment mechanism or handle prior to deployment issue.The device did not pass through a previously deployed stent.The lesion was not pre-dilated.  no resistance was encountered when advancing the device.The thumb switch was checked for securement prior to procedure and lock pin was removed just prior to deployment once the device crossed the lesion site.The physician started to turn the thumb wheel to retract the sheath and deploy the stent.The audible clicks were heard once the sheath started to retract, then after roughly 2cm of stent deployment the sheath stopped retracting even though the thumbwheel continued to move and audible clicks were heard.The procedure was completed by separating the deployment handle and retracting the inner sheath manually in a pin-pull system to fully retract the sheath and fully deploy the abre stent.The procedure was very successful and ended without complication, no vessel damage noted.No patient discomfort and patient went home few hours later.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: the abre device was returned to medtronic investigation lab for evaluation.The device was returned coiled inside a biohazard pouch inside a shelf carton.The device returned with the handle separated and the wheel removed from the handles.A kink was observed on thumb wheel wire.The size on the strain relief is consistent with what was reported in the file.Kink observed on tubing.Kink observed on inner tubing.Biologics observed on blue tubing.Approximately 89mm of the inner tubing was advanced out of sheath.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12697901
• Report Number: 2183870-2021-00389
• Device Sequence Number: 11775156
• Product Code: QAN
• UDI-Device Identifier: 00643169796379
• UDI-Public: 00643169796379
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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: 08/16/2024
• Device Model Number: AB9U16150090
• Device Catalogue Number: AB9U16150090
• Device Lot Number: B250974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 100 KG