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

Model Number H74912044186070

Device Problems Difficult to Advance (2920); Positioning Problem (3009)

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

Event Date 01/11/2023

Event Type  Injury  

Event Description

It was reported that the stent was difficult to position.The patient presented with may-thurner syndrome and underwent stenting.The 74% stenosed target lesion was located in the moderately tortuous and non-calcified iliac vein.An 18x60x75cm venous wallstent was advanced over a non-boston scientific guidewire with much difficulty.The stent was deployed and post-dilated with a 12mm charger balloon with good vessel apposition.However, the physician was unhappy with the placement of the stent and decided to deploy a 18x90 venous wallstent to anchor and reinforce the previously deployed stent.The physician felt the stent was maldeployed and commented on appearance of webbing in the iliac vein.No patient complications were reported.

• 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: 16295405
• MDR Text Key: 308765462
• Report Number: 2124215-2023-02822
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 08714729979609
• UDI-Public: 08714729979609
• 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
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74912044186070
• Device Catalogue Number: H74912044186070
• Device Lot Number: 0030004568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 57 KG