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

Model Number 20226

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 07/22/2020

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred.The more than 90% stenosed target lesion was located in the severly tortuous left common and external iliac arteries.A 9.0x40x75cm express ld iliac / biliary stent was advanced for treatment.However, it was noted that the stent came off its balloon when removing the stent to exchange guidewires.The balloon was removed and the undeployed stent was seen in the sheath inside the body.The physician used a small balloon and inserted it through the undeployed stent which was then subsequently advanced and deployed safely into the external iliac artery (eia).After stent implantation in the eia, another 9.0x40x75cm express ld stent was handed off to treat the left common iliac artery.However, it was noticed that the balloon in which the stent is mounted was winged out at the distal portion.The physician decided not to used the stent and finished the procedure with another of the same device.No harm was caused to the patient.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10345150
• MDR Text Key: 201076490
• Report Number: 2134265-2020-10188
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392330
• UDI-Public: 08714729392330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0021615968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention