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

Model Number	H74912044189070
Medical Device Problem Codes	Mechanical Problem (1384); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent foreshortened and was unable to be reconstrained.A 18mm x 90mm x 75cm venous wallstent was selected for use in the left common iliac vein for treatment of may-thurner syndrome.The target lesion was 70% stenosed with no vessel tortuosity.During the procedure while trying to deploy the venous wallstent, the stent kept foreshortening.An attempt was made to recapture the stent and move it more proximal, but the stent would not re-sheath.The system would not move back over the stent, and it was noted by the physician to be well above the point of no return.The stent was ultimately deployed.A 18mm x 60mm x 75cm venous wallstent was placed on the proximal end of the first stent where it had foreshortened.No patient complications were reported.
Event or Problem Description
It was reported that the stent foreshortened and was unable to be reconstrained.A 18mm x 90mm x 75cm venous wallstent was selected for use in the left common iliac vein for treatment of may-thurner syndrome.The target lesion was 70% stenosed with no vessel tortuosity.During the procedure while trying to deploy the venous wallstent, the stent kept foreshortening.An attempt was made to recapture the stent and move it more proximal, but the stent would not re-sheath.The system would not move back over the stent, and it was noted by the physician to be well above the point of no return.The stent was ultimately deployed.A 18mm x 60mm x 75cm venous wallstent was placed on the proximal end of the first stent where it had foreshortened.No patient complications were reported.

• 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: 13535264
• Report Number: 2134265-2022-01444
• Device Sequence Number: 14462884
• Product Code: QAN
• UDI-Device Identifier: 08714729979616
• UDI-Public: 08714729979616
• 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): 02/15/2022

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: 06/02/2023
• Device Model Number: H74912044189070
• Device Catalogue Number: H74912044189070
• Device Lot Number: 0027422953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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 Sex: Female