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

Model Number	20226
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the superficial femoral vein.A 8.0x40x135 cm express ld iliac / biliary stent was advanced for treatment.However, the physician wanted to perform plain old balloon angioplasty (poba) again and the stent was withdrawn.Upon withdrawal, the stent got stuck in the edge sheath and dislodged.The stent was removed by open procedure.No further patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the superfical femoral vein.A 8.0x40x135 cm express ld iliac/biliary stent was advanced for treatment.However, the physician wanted to perform plain old balloon angioplasty (poba) again and the stent was withdrawn.Upon withdrawal, the stent got stuck in the edge sheath and dislodged.The stent was removed by open procedure.No further patient complications were reported.It was further reported the stent dislodged in the iliac vein.Open surgery occurred to remove the stent and complete the procedure.Post procedure, the patient was stable and discharged.

• 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: 7801538
• Report Number: 2134265-2018-60343
• Device Sequence Number: 2488963
• Product Code: NIO
• UDI-Device Identifier: 08714729392477
• UDI-Public: 08714729392477
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 10/05/2020
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0021223051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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