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

Model Number AB9U14120090

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use an abre venous stent with a 9fr sheath during treatment of the patient¿s proximal left common iliac vein.Ifu was followed and the device was prepped without issue.It is reported that the physician noted the retractable sheath seemed slightly pulled back from tip of device, but decided it was negligible and proceeded with delivery.The device was not passed through a previously deployed stent.No resistance was noted during advancement.There was enough distal landing zone.Upon delivery, physician noted that the stent jumped forward and distal portion of stent was bent on an angle.Physician attributed this movement and mis-deployment to the state of the retractable sheath prior to delivery.The stent placement did not compromise delivery and the physician was able to use a balloon to straighten out the distal portion of the stent to successfully complete the procedure.No patient injury reported.

Manufacturer Narrative

Additional information: the stent did not elongate.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
• MDR Report Key: 10968180
• MDR Text Key: 220731854
• Report Number: 2183870-2020-00425
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00643169796317
• UDI-Public: 00643169796317
• Combination Product (y/n): N
• PMA/PMN Number: P200026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2023
• Device Model Number: AB9U14120090
• Device Catalogue Number: AB9U14120090
• Device Lot Number: B080107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR