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

Model Number	20226
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Activation Failure (3270)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that device detachment occurred.An 8.0 x 40 x 135 cm express ld stent was advanced for treatment.However, before reaching the nominal pressure, the stent detached with the balloon.Another balloon was used to make the stent fully deploy.There were no further patient complications nor injuries reported and the patient's status was stable.
Event or Problem Description
It was reported that device detachment occurred.An 8.0x40x135 cm express ld stent was advanced for treatment.However, before reaching the nominal pressure, the stent detached with the balloon.Another balloon was used to make the stent fully deploy.There were no further patient complications nor injuries reported and the patient's status was stable.It was further reported that the 75% stenosed target lesion was located in the non-tortuous and moderately calcified iliac artery.Both the stent and the balloon did not detached from the shaft.The stent was deployed from the balloon prior to full balloon expansion.
Additional Manufacturer Narrative
B1 adverse event/product problem corrected from product problem to adverse event and product problem.A2- age at time of event: 18 years or older.

• 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: 10264868
• Report Number: 2134265-2020-09218
• Device Sequence Number: 14318578
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: 11/28/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024848908
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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