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	04/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.A 8.0x30x75cm express ld stent was inserted within the patient and then there was an attempt to remove the device; however, during the removal the stent dislodged within the patient.A mustang balloon catheter was used to successfully retrieve the stent.The procedure was completed with another stent.No patient harm or complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the stent detached from the balloon.The balloon catheter was not returned for analysis.The stent was received advance on to the shaft of a mustang balloon catheter.A microscopic examination found rows 1-6 of the proximal stent struts to be severely damaged.This type of damage is consistent with excessive force being applied to the device as the user attempts to remove it from the patient.No other issues were identified with the stent that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.A 8.0x30x75cm express ld stent was inserted within the patient and then there was an attempt to remove the device; however, during the removal the stent dislodged within the patient.A mustang balloon catheter was used to successfully retrieve the stent.The procedure was completed with another stent.No patient harm or complications were reported.

• 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: 8600024
• Report Number: 2134265-2019-05079
• Device Sequence Number: 2281090
• Product Code: NIO
• UDI-Device Identifier: 08714729579670
• UDI-Public: 08714729579670
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/10/2019

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: 10/25/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022850526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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