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

Model Number	20226
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/01/2020
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 stent deployed during advancement.A 7.0 x 60 x 135 cm express ld iliac / biliary stent was advanced for treatment.During the procedure, the stent slide out when the physician tried to approach the target lesion.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that stent deployed during advancement.A 7.0x60x135 cm express ld iliac / biliary stent was advanced for treatment.During the procedure, the stent slide out when the physician tried to approach the target lesion.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the stent was prematurely deployed during crossover procedure and was implanted in the patient's body.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.Device evaluated by mfr.: express ld device - 7.0x60x135cm was returned for analysis.The device was returned with the stent completely detached from the device.A visual and microscopic examination identified that the stent had been completely detached from the device.There is no indication that the detached stent had been dilated.A microscopic examination found the stent struts to be damaged along the entire length of the stent.The stent damage most probably occurred when attempting to withdraw the device back to reposition it.No other issues were identified with the stent that could potentially have contributed to the complaint incident.A visual examination identified that the balloon had not been subjected to positive pressure.The stent crimp marks were clearly visible on the balloon material.A visual and microscopic examination identified no issues with the balloon material 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 damage or any issues along the length of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent deployed during advancement.A 7.0x60x135 cm express ld iliac / biliary stent was advanced for treatment.During the procedure, the stent slide out when the physician tried to approach the target lesion.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the stent was prematurely deployed during crossover procedure and was implanted in the patient's body.It was further reported that the device was retrieved and was not implanted.

• 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: 10272175
• Report Number: 2134265-2020-09189
• Device Sequence Number: 10965517
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2020

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: 10/30/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024687969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/13/2020; 07/27/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/21/2020; 08/04/2020
• 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