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

Model Number	20226
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or below.(b)(6).Device evaluated by mfr.: an express-b-i ld pmtd 7.0x60x135 cm was returned for analysis.The device was returned with a 6fr guide catheter.A visual and microscopic examination found that the stent had detached from the device.The stent was found in the 6fr guide catheter that was returned by the customer.The balloon was received tightly folded which indicates it had not been subjected to positive pressure.No issues were noted with balloon that could potentially have contributed to the complaint incident.A visual and microscopic examination of the device identified no issues with the markerbands or tip.A visual and tactile examination of the shaft identified multiple outer kinks.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21jul2020.It was reported that catheter entrapment occurred.The target lesion was located in the non-tortuous and mildy calcified iliac artery.A 7.0x60x135 cm express ld stent was advanced for treatment.However, during advancing, the device was stuck in the sheath.Both devices were removed from the patient's body as a unit.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent detached/separated.

• 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: 10376020
• Report Number: 2134265-2020-10452
• Device Sequence Number: 2476486
• Product Code: NIO
• UDI-Device Identifier: 08714729392453
• UDI-Public: 08714729392453
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 12/17/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024949823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1