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

Model Number	AB9U16150090
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2022
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
A physician was implanting an abre stent system for the treatment of a calcified lesion with 50% stenosis in the right proximal common iliac vein.  a 9fr non-mdt sheath and.035 guidewire were used.The device was prepped as per the ifu with no issues identified.It was reported that deployment issues were experienced and the device was unable to deploy.Resistance was encountered and force was applied.The thumbscrew/lock-pin was checked for securement prior to procedure and the lock-pin was removed prior to deployment. the thumbwheel was difficult to rotate on the 1st and 2nd rotation, but the physician pressed hard to rotate thumbwheel.3rd and 4th rotation was more difficult to rotate and then the thumbwheel stopped and wouldn't rotate any further.The physician broke the handle, removed the clip and used pin/pull method to deploy the stent.The abre stent enlongated so they had to re line with 3 additional abre stents.
Additional Manufacturer Narrative
Product analysis device returned with an introducer, the protective sheath and the handle opened (photo 4).The introducer was filled with biologics.A kink was observed on the inner tubing.Approximately 155mm of the inner tubing was exposed the handle returned opened.Not all components of the handle was returned.The wire inside the handle was damaged no damage was observed to the protective sheath image analysis three images were provided for evaluation.In the image provided you can see that the stent appears to be elongated and deformed.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: 15416463
• Report Number: 2183870-2022-00297
• Device Sequence Number: 20464534
• Product Code: QAN
• UDI-Device Identifier: 00643169796379
• UDI-Public: 00643169796379
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/15/2022

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: 07/14/2025
• Device Model Number: AB9U16150090
• Device Catalogue Number: AB9U16150090
• Device Lot Number: B416347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 130 KG