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

Model Number	AB9U12100090
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
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 self expanding stent to treat moderately calcified fibrous lesion in the mid right common iliac vein.Patient hydrated prior to implant procedure.Ivus used for stent measuring and sizing.The vessel had moderate tortuosity.The artery diameter was 18mm and lesion length was 100mm.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.The lesion was pre-dilated with a 20mm pre-dilation device.The device did pass through a previously deployed stent.There was no resistance encountered when advancing the device.It was reported that the wrong diameter stent was placed into patient from right jugular access, stent intended to overlap a previously deployed 16mmx80mm abre in the cf/external iliac vein.The 12mmx100mm abre stent was deployed inside the 16x80 and was floating on the wire.A 20mmx40mm balloon was inserted to post dilate the 12x100 stent, the stent was still floating on the wire.A 20mmx120mm stent was then deployed inside the 12x100 and overlapping proximal and distal into common <(>&<)> external vein.The 20mmx120mm stent trapped the 12x100 and then both stents were post dilated to 20mmx40mm with a non medtronic high pressure balloon.No issues with deployment of abre stent.Ivus was inserted to confirm the smaller stent was trapped and all stents had vein wall apposition. venogram was preformed to confirm blood flow and then everything was removed from the body to complete the case.Patient was not harmed and was moved to cvop.No patient injury.

• 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: 13008772
• Report Number: 2183870-2021-00456
• Device Sequence Number: 19306214
• Product Code: QAN
• UDI-Device Identifier: 00643169796249
• UDI-Public: 00643169796249
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2023
• Device Model Number: AB9U12100090
• Device Catalogue Number: AB9U12100090
• Device Lot Number: B120748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/15/2021
• Date Device Manufactured: 11/19/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male