MAUDE Adverse Event Report: MEDTRONIC, INC. ABRE; STENT, ILIAC VEIN

Model Number AB9U20120090

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

The abre¿ venous self-expanding stent system was placed in the patient.When the stent was deployed, it only partially deployed.The sds and the sheath were not able to be removed from the patient after many efforts to fully deploy the stent.It was deemed that the patient required surgical intervention.

• Brand Name: ABRE
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 12091792
• MDR Text Key: 259141322
• Report Number: 12091792
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AB9U20120090
• Device Lot Number: B201816
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2021
• Date Report to Manufacturer: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23725 DA