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	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: selected (b)(6) 2018 (first date of the month of the aware date) as no event date was reported implant dated: selected (b)(6) 2018 (first date of the month of the aware date as no event/implant date was reported).
Event or Problem Description
It was reported that stent dislodgement occurred.A 6.0x30x135cm express ld iliac / biliary stent was used for treatment.It was noticed that the stent was extended through calcium and the stent came loose from the balloon, and it dislodge in the arm, and an unspecified 3mm balloon was inserted over an unspecified 035 wire to "post the balloon." no patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Date of event updated from (b)(6) 2018 to (b)(6) 2018.Implant date updated from (b)(6) 2018 to (b)(6) 2018.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 08:59 am ct.The report number is being corrected from: 2134265-2018-64151 to: 2134265-2018-63114.
Event or Problem Description
It was reported that stent dislodgement occurred.A 6.0x30x135cm express ld iliac / biliary stent was used for treatment.It was noticed that the stent was extended through calcium and the stent came loose from the balloon, and it dislodge in the arm, and an unspecified 3mm balloon was inserted over an unspecified 035 wire to "post the balloon." no patient complications were reported and the patient was stable.It was further reported that the stent was retrieved and successfully implanted using an unspecified 3mm balloon that was inserted over an unspecified 035 wire.

• 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: 8097298
• Report Number: 2134265-2018-63114
• Device Sequence Number: 19519216
• Product Code: NIO
• UDI-Device Identifier: 08714729579687
• UDI-Public: 08714729579687
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 09/25/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022709753
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 11/24/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 01/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention