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	Vascular Dissection (3160)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, stent inadequate apposition, and vessel dissection occurred.The target lesion was located in the left common iliac vessel.Following pre-dilatation with an 8x40 balloon, a 10.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, upon inflating the balloon inside the stent, the balloon ruptured.The balloon was pulled out.The stent was noted to be dog-boned, which could not fully inflate the stent.Another non-bsc balloon was used to post dilate the stent.There was a slight dissection noted from the common iliac towards the aorta and the physician post dilated it again with the non-bsc balloon.No further patient complications were reported and the patient did good.
Event or Problem Description
It was reported that balloon rupture, stent inadequate apposition, and vessel dissection occurred.The target lesion was located in the left common iliac vessel.Following pre-dilatation with an 8x40 balloon, a 10.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, upon inflating the balloon inside the stent, the balloon ruptured.The balloon was pulled out.The stent was noted to be dog-boned, which could not fully inflate the stent.Another non-bsc balloon was used to post dilate the stent.There was a slight dissection noted from the common iliac towards the aorta and the physician post dilated it again with the non-bsc balloon.No further patient complications were reported and the patient did good.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the stent detached from the balloon.The stent was not returned for analysis as it was deployed during the procedure.Blood was identified in the balloon which is indicative of a leak.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from a balloon pinhole 5mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.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 issues with the shaft that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.

• 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: 9799961
• Report Number: 2134265-2020-02700
• Device Sequence Number: 2815401
• Product Code: NIO
• UDI-Device Identifier: 08714729392071
• UDI-Public: 08714729392071
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 08/15/2020
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0021015198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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
• Patient Age: 60 YR