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

Model Number	H74912044169070
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wallstent deployed within the sheath and the stent had to be removed via a small cut incision.A 16x90x75 venous wallstent was selected for use for a venogram procedure in the distal common iliac vein.The lesion was near occluded and the tortuosity was very complex.The lesion was predilated to 12mm.During the procedure, the entire stent was reported to have deployed in the 8fr sheath.The stent was removed from the patient via a small cutdown incision.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
• MDR Report Key: 11902270
• Report Number: 2134265-2021-06716
• Device Sequence Number: 3742197
• Product Code: QAN
• UDI-Device Identifier: 08714729979586
• UDI-Public: 08714729979586
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: 11/16/2022
• Device Model Number: H74912044169070
• Device Catalogue Number: H74912044169070
• Device Lot Number: 0026369686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention