MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VENOUS WALLSTENT; STENT, ILIAC VEIN

Model Number H74912044169070

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 01/19/2022

Event Type  Injury  

Event Description

It was reported that a stent occlusion occurred.On (b)(6) 2019, a 16 x 90 x 75cm venous wallstent was placed in the left iliac vein for a venous compression procedure.On (b)(6) 2022, the patient was hospitalized for swelling of her left lower extremity.Venogram showed occlusion of the wallstent implanted in the left iliac vein.Attempts to cross the wallstent with wires and catheters were unsuccessful.The patient was referred to a vascular surgeon.After consult with the vascular surgeon, the patient was scheduled for venous bypass.On (b)(6) 2022, the vascular surgeon performed left femoral to right femoral vein bypass utilizing reversed autogenous saphenous vein.On (b)(6) 2022, the patient was admitted for continuing symptoms.The physician attempted to access the occluded left iliac vein stent through both the right arm and left femoral vein.Attempts to cross the stent were unsuccessful.The physician is planning on referring the patient to a specialist.The procedure was aborted.At the time of reporting the issue is ongoing.

• Brand Name: VENOUS WALLSTENT
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14322613
• MDR Text Key: 291198900
• Report Number: 2134265-2022-05090
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980033/S050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H74912044169070
• Device Catalogue Number: H74912044169070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Race: White