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

Model Number H74912044189070

Device Problem Migration (4003)

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

Event Date 03/29/2022

Event Type  Injury  

Event Description

It was reported that stent migration occurred.The patient presented with may-thurner syndrome.Two venous wallstents were selected for use.Both wallstents were successfully deployed in the right and left iliac veins and joined each other in the inferior vena cava (ivc).Intravascular ultrasound (ivus) was used in the left iliac and no issues were noticed.Upon examining the right iliac with ivus, the wallstent had migrated to the distal ivc.The physician believed the stent had not been anchored at the bottom and migrated due o severe disease in the right external iliac vein.The physician used a wire to pull the wallstent down to the confluence of the ivc and the ostial right iliac vein.An additional wallstent was then used to anchor the stent.The procedure was completed without any further issues.There were no patient complications.

Manufacturer Narrative

H1 - type of reportable event: corrected to serious injury.

Event Description

It was reported that stent migration occurred.The patient presented with may-thurner syndrome.Two venous wallstents were selected for use.Both wallstents were successfully deployed in the right and left iliac veins and joined each other in the inferior vena cava (ivc).Intravascular ultrasound (ivus) was used in the left iliac and no issues were noticed.Upon examining the right iliac with ivus, the wallstent had migrated to the distal ivc.The physician believed the stent had not been anchored at the bottom and migrated due o severe disease in the right external iliac vein.The physician used a wire to pull the wallstent down to the confluence of the ivc and the ostial right iliac vein.An additional wallstent was then used to anchor the stent.The procedure was completed without any further issues.There were no patient complications.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14190613
• MDR Text Key: 289950749
• Report Number: 2134265-2022-04546
• 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,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74912044189070
• Device Catalogue Number: H74912044189070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female