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

Model Number	H74912044164070
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent foreshortened.A 16mm x 40mm x 75cm venous wallstent was selected for use in an iliac vein stenting procedure.After measuring the left common iliac for size by intravascular ultrasound (ivus), it was determined that the vessel was 12mm.After the stent was deployed and post dilated with a 16mm balloon, ivus was used to visualize the stent; the stent had good wall apposition.There was also good flow by venogram, but it was observed that the stent foreshortened approximately 10mm from the distal end.Upon advancing the ivus catheter to measure the length needed for a second stent, it was noticed under fluoroscopy that the stent turned on its side within the vessel.At this point, the physician felt that the stent was undersized and an 18mm stent was needed in order to entrap the first stent.An 18mm x 60mm x 75cm venous wallstent was advanced and deployed entrapping the 16mm x 40mm stent.There was good flow seen by venogram post stenting, and good wall apposition was noted by ivus.The patient did well and there were no other complications.The patient fully recovered.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14516711
• Report Number: 2134265-2022-06028
• Device Sequence Number: 17774809
• Product Code: QAN
• UDI-Device Identifier: 08714729979562
• UDI-Public: 08714729979562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 05/26/2022

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: 07/28/2023
• Device Model Number: H74912044164070
• Device Catalogue Number: H74912044164070
• Device Lot Number: 0027742405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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: 57 YR
• Patient Sex: Male
• Patient Race: White