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

Model Number	H74912044189070
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent migrated.An 18x90x75cm venous wallstent was selected and 16x60x75cm wallstent endoprosthesis were selected for use within the right common iliac vein and external iliac vein.The lesion was 50% stenosed, non-calcified, and non-tortuous.The venous wallstent was placed in the right 15.5mm diameter common iliac vein and the wallstent endoprosthesis was overlapped approximately 2cm into the 14mm diameter vessel extending into the right external iliac vein.Post dilation was performed.The stents were fully apposed.After, the venous wallstent migrated into the inferior vena cava (ivc) and the wallstent endoprosthesis migrated slightly as well.Due to the migration, another 18x90 wallstent was placed between the initial two implanted stents.No additional migration was observed.There were no patient complications and the patient was fine.

• Brand Name: VENOUS WALLSTENT
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10826095
• Report Number: 2134265-2020-15740
• Device Sequence Number: 2953860
• Product Code: QAN
• UDI-Device Identifier: 08714729979616
• UDI-Public: 08714729979616
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2022
• Device Model Number: H74912044189070
• Device Catalogue Number: H74912044189070
• Device Lot Number: 0025813978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR