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

Model Number	H74912044166070
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Unspecified Heart Problem (4454)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stents migrated and required explant.On (b)(6) 2020, a 16x60 venous wallstent was implanted in the external iliac vein.The patient presented with right common iliac and external iliac vein compression.Ivus imaging was obtained along with measurements, and a pre-dilation of the common iliac and external iliac was performed with a 14x60 and a 16x60 xxl balloon.An additional ivus run was recorded, and it was noted that there was recoil.The decision was made to place a 14x60 vici stent in the right common iliac vein.There was still compression in the external iliac vein, so an additional stent (16x60 venous wallstent) was placed in the external iliac vein.Post dilation of the stents was performed.A follow up intravascular ultrasound exam revealed significant improvement with an increase in cross-sectional area.A venogram was also performed, and the physician completed the procedure.Patient tolerated the procedure well and recovered with no complications.6-month follow ups were performed with ultrasound, and the stents were intact.Sometime in the two weeks prior to (b)(6) 2022, the patient presented with heart palpitations.Both the vici and venous wallstent had migrated to the right atrium (ra).The patient was referred for endovascular stent retrieval.Both stents were removed from the ra using forceps via femoral vein access on (b)(6) 2022.The patient tolerated the procedure and is expected to make a full recovery.
Additional Manufacturer Narrative
Date of event estimated using date of stent explantation.
Event or Problem Description
It was reported that the stents migrated and required explant.On (b)(6) 2020, a 16x60 venous wallstent was implanted in the external iliac vein.The patient presented with right common iliac and external iliac vein compression.Ivus imaging was obtained along with measurements, and a pre-dilation of the common iliac and external iliac was performed with a 14x60 and a 16x60 xxl balloon.An additional ivus run was recorded, and it was noted that there was recoil.The decision was made to place a 14x60 vici stent in the right common iliac vein.There was still compression in the external iliac vein, so an additional stent (16x60 venous wallstent) was placed in the external iliac vein.Post dilation of the stents was performed.A follow up intravascular ultrasound exam revealed significant improvement with an increase in cross-sectional area.A venogram was also performed, and the physician completed the procedure.Patient tolerated the procedure well and recovered with no complications.6-month follow ups were performed with ultrasound, and the stents were intact.Sometime in the two weeks prior to (b)(6) 2022, the patient presented with heart palpitations.Both the vici and venous wallstent had migrated to the right atrium (ra).The patient was referred for endovascular stent retrieval.Both stents were removed from the ra using forceps via femoral vein access on (b)(6) 2022.The patient tolerated the procedure and is expected to make a full recovery.It was further reported that the patient went to the hospital on (b)(6) 2022 for atrial fibrillation and was discharged on (b)(6) 2022.The stents were not discovered during this time.On (b)(6) 2022, there was a consult for removal of stents in the ivc/ra.

• Brand Name: VENOUS WALLSTENT
• Common Device Name: 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: 15720974
• Report Number: 2124215-2022-43824
• Device Sequence Number: 7542267
• Product Code: QAN
• UDI-Device Identifier: 08714729979579
• UDI-Public: 08714729979579
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P980033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2022
• Device Model Number: H74912044166070
• Device Catalogue Number: H74912044166070
• Device Lot Number: 0026023257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 118 KG