MAUDE Adverse Event Report: MEDTRONIC / EV3, INC. ABRE VENOUS SELF-EXPANDING STENT; STENT, ILIAC VEIN

Model Number AB9U16060090

Device Problems Fracture (1260); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 boston scientific vici venous stent 16mmx120mmx100cm left external iliac h74916120100 - lot 19120020, 16mmx90mmx100cm vici venous stent 16x90mmx100cm right external iliac h74916090100 - lot 19090051.On (b)(6) 2021 left stent occluded, venogram, lysis catheter, thrombectomy, on (b)(6) 2021 venogram, bs stent fracture, medtronic abre venous self expanding stent system 16mmx60mm ab9u16060090 - lot b078277, on (b)(6) 2021 venogram left.Fda safety report id# (b)(4).

• Brand Name: ABRE VENOUS SELF-EXPANDING STENT
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): MEDTRONIC / EV3, INC.
• MDR Report Key: 13141848
• MDR Text Key: 283161584
• Report Number: MW5106402
• Device Sequence Number: 2
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: AB9U16060090
• Device Lot Number: B078277
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2021
• Patient Sequence Number: 1
• Treatment: AMITRIPTYLINE 10MG; CLOPIDOGREL 75 MG ; ELIQUIS 5MG ; PHENAZOPYRIDINE 200 MG ; PLAVIX ; TYLENOL ; ZOLPIDEM 10 MG AS NEEDED ; ZYRTEC
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White