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	07/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right iliac vessel.A 8.0x40x75cm express ld iliac / biliary was advanced to treat the lesion.However, when the physician pulled back the device for stent placement, the stent came off of the balloon.All devices were removed and the stent was successfully removed from access site.The procedure was completed was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right iliac vessel.A 8.0x40x75cm express ld iliac / biliary was advanced to treat the lesion.However, when the physician pulled back the device for stent placement, the stent came off of the balloon.All devices were removed and the stent was successfully removed from access site.The procedure was completed was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned with the stent detached from the balloon.The customer's 5fr guide catheter was returned for analysis and was found to be ruptured at approximately 53mm proximal of the distal end of the device.The balloon was noted to be tightly folded and had not been subjected to positive pressure.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.The device was returned with the stent completely detached from the balloon catheter.The stent struts were noted to be bent along its entire length.Severe damage was noted at one end of the stent.This type of damage is consistent with excessive force being applied to the stent.No other issues were identified with the stent that could potentially have contributed to the complaint incident.A visual and microscopic examination identified no issues with the tip of the device during analysis that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.

• 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: 8808085
• Report Number: 2134265-2019-08495
• Device Sequence Number: 2693406
• Product Code: NIO
• UDI-Device Identifier: 08714729392279
• UDI-Public: 08714729392279
• 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): 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0023765606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR