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

Model Number	20226
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred, requiring an additional device.The target lesion was located in the mildly tortuous and non-calcified iliac and renal arteries.Following pre-dilatation with a 6.0 x 80, 135cm mustang balloon catheter and placing a new 7f non-boston scientific sheath, a 8.0x40x75cm express ld stent was selected for use.However, when the express ld went over the bifurcation and was just about to be placed over the lesion, the stent dislodged.The physician decided to leave the stent and deployed it using a new mustang balloon catheter.Another express ld stent was used to cover the remainder of the lesion.There were no complications reported and the patient was scheduled for follow-up.
Additional Manufacturer Narrative
Device evaluated by mfr.: the express ld was returned for analysis.The balloon was received loosely folded.The balloon appears to have been subjected to positive pressure.No stent received on balloon material.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination of the device identified no issues with the markerbands or tip.
Event or Problem Description
It was reported that stent dislodgement occurred, requiring an additional device.The target lesion was located in the mildly tortuous and non-calcified iliac and renal arteries.Following pre-dilatation with a 6.0 x 80, 135cm mustang balloon catheter and placing a new 7f non-boston scientific sheath, a 8.0x40x75cm express ld stent was selected for use.However, when the express ld went over the bifurcation and was just about to be placed over the lesion, the stent dislodged.The physician decided to leave the stent and deployed it using a new mustang balloon catheter.Another express ld stent was used to cover the remainder of the lesion.There were no complications reported and the patient was scheduled for follow-up.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18845561
• Report Number: 2124215-2024-10797
• Device Sequence Number: 15536971
• Product Code: NIO
• UDI-Device Identifier: 08714729392279
• UDI-Public: 08714729392279
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: 04/26/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027213299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7F DESTINATION SHEATH; 7F DESTINATION SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: Black Or African American