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

Model Number	20226
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodged inside the patient.The target lesion was located in the severely calcified and very tight proximal external right iliac.A right sided puncture was performed and stayed true lumen by using a 6fr non-bsc sheath.A 7.0x40x75cm express ld iliac / biliary stent was advanced for treatment.However, during the procedure, when the physician advanced the express ld stent delivery system out through the sheath, it was noted that the stent immediately fell off the delivery system.Only the balloon catheter advanced while the stent remained just outside the sheath.The physician then used a 4fr non-bsc catheter to push the stent across the stenosis and was able to inflate a 4mm mustang balloon to partially expand the stent.Post dilation was then performed with the 7mm express ld balloon catheter.The result was not optimal, so the physician used a non-bsc covered stent across a segment of stenosis that was not covered by the express ld stent.There were no patient complications 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: 8561104
• Report Number: 2134265-2019-04498
• Device Sequence Number: 2191430
• Product Code: NIO
• UDI-Device Identifier: 08714729392217
• UDI-Public: 08714729392217
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 11/23/2020
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0021428645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/29/2019
• 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: Other