MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: mid 70's.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left external iliac artery.A 7.0x30x135cm express ld iliac / biliary stent was advanced to treat the lesion.It was noted to be the wrong length stent.The stent delivery system was attempted to be removed; however, the stent came off the balloon.A smaller balloon was then used to dilate the dislodged stent in the left external iliac artery and the procedure was completed.No further patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Age at time of event: mid 70's.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left external iliac artery.A 7.0x30x135cm express ld iliac / biliary stent was advanced to treat the lesion.It was noted to be the wrong length stent.The stent delivery system was attempted to be removed; however, the stent came off the balloon.A smaller balloon was then used to dilate the dislodged stent and the procedure was completed.No further patient complications were reported and the patient was fine.It was further reported that the target lesion was non-tortuous and moderately calcified.The stent fell off the balloon while trying to retrieve the undeployed system from the body and the stent was deployed where it lodged.Additional stenting was done to treat the target lesion and the procedure was completed.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9591757
• Report Number: 2134265-2020-00120
• Device Sequence Number: 3244301
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: 08714729579694
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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: 11/06/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024727106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/14/2020
• 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