MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent foreshortening occurred requiring additional intervention.The 65% stenosed target lesion was located in the non-tortuous and non-calcified proximal left common iliac vein (civ).A 20x80/10fr uni plus 75cm wallstent uni stent was advanced for treatment.However, during procedure, there was difficulty deploying the stent.The stent kept dropping near final deployment so it had to be recaptured twice.The stent was successfully implanted; however, it foreshortened near the civ so an additional proximal stent was used.No patient complications were reported.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11977500
• Report Number: 2134265-2021-07509
• Device Sequence Number: 11628970
• Product Code: JCT
• UDI-Device Identifier: 08714729204114
• UDI-Public: 08714729204114
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/10/2021

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: 09/10/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0025993890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention