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

Model Number	20226
Medical Device Problem Codes	Material Rupture (1546); Activation Failure (3270)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and serious damage to the vessel occurred.The 60% stenosed target lesion was located in the non-tortuous and non-calcified iliac artery.A 7.0x30x135cm express ld stent was advanced for treatment.The front side of the device was deployed and attached to the vessel; however, when the balloon was inflated, the balloon ruptured.During removal of the device, it was noticed that the vessel was seriously damaged.The physician used a snare wire to retrieve the device.The procedure was completed with another of the same device.No further patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluation by mfr: the complaint device was returned for analysis.A visual and microscopic examination identified that the stent had been moved to a position that was approximately 10mm distal of the proximal marker band on the device.A microscopic examination found the stent had been pushed over the distal balloon cone causing the first two rows of the distal stent struts to lift.No other issues were identified with the stent that could potentially have contributed to the complaint incident.A visual examination identified blood inside the balloon.To facilitate identifying the location of the device leak the investigator moved the stent proximally from the balloon material.A visual and microscopic examination identified a balloon longitudinal tear beginning 3mm proximal of the distal tip and extending approximately 8mm proximally across the balloon material.An examination of the balloon material and distal marker band identified no issues which could potentially have contributed to this complaint.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 balloon rupture and serious damage to the vessel occurred.The 60% stenosed target lesion was located in the non-tortuous and non-calcified iliac artery.A 7.0x30x135cm express ld stent was advanced for treatment.The front side of the device was deployed and attached to the vessel; however, when the balloon was inflated at 2 atmospheres, the balloon ruptured.During removal of the device, it was noticed that the vessel was seriously damaged.The physician used a snare wire to retrieve the device.The procedure was completed with another of the same device.No further patient complications were reported and the patient's status was stable.

• 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: 10143942
• Report Number: 2134265-2020-07803
• Device Sequence Number: 3053353
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: 08714729579694
• 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,Followup
• Report Date (Section B): 07/01/2020

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: 07/11/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024096324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/01/2020
• 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