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

Model Number	H74912044208070
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device interaction with another device occurred.The patient was being treated for venous compression and underwent left common iliac venous stent placement with balloon angioplasty.The 50% or greater stenosed target lesion was located in the non-tortuous and non-calcified left common iliac artery.After a 20x80x75cm venous wallstent was advanced and fully deployed, a 18-6/5.8/75 xxl esophageal balloon catheter was advanced for post-dilatation.However, during second inflation at 5 atmospheres for 10 seconds, the balloon ruptured due to contact with the stent struts.Difficulty removal of the balloon through the sheath was encountered and when the catheter was pulled, the balloon remains on the catheter.Furthermore, the physician accessed superior to the balloon and used a non-bsc to snare in order to retrieve and remove the excess balloon that was lodged in the popliteal vein.It was noted that the stent was fully apposed to the vessel wall and the procedure was completed successfully.The patient condition was good post-procedure and was 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16703271
• Report Number: 2124215-2023-15172
• Device Sequence Number: 20251427
• Product Code: QAN
• UDI-Device Identifier: 08714729979647
• UDI-Public: 08714729979647
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980033/S050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2025
• Device Model Number: H74912044208070
• Device Catalogue Number: H74912044208070
• Device Lot Number: 0030925390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White