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

Model Number	20226
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent inadequate apposition, balloon rupture and difficulty removal occurred.An express sd renal/biliary stent was advanced for treatment.However, during balloon expansion, the balloon ruptured and was not able to be removed from the stent after many tries.The stent was only expanded on the distal tip.Both the stent and balloon are still in the patient.Intervention is planned to remove both the stent and balloon.No further complications were reported.
Additional Manufacturer Narrative
(e1) initial reported title, first name and last name: updated to dr.(b)(6).
Event or Problem Description
It was reported that stent inadequate apposition, balloon rupture and difficulty removal occurred.An express sd renal/biliary stent was advanced for treatment.However, during balloon expansion, the balloon ruptured and was not able to be removed from the stent after many tries.The stent was only expanded on the distal tip.Both the stent and balloon are still in the patient.Intervention is planned to remove both the stent and balloon.No further complications were reported.
Additional Manufacturer Narrative
D4 updated from unknown: 1.Model number/catalog number.2.Lot number.3.Expiration date.4.Unique identifier (udi) #.Device was evaluated by mfr.Returned product consisted of an express ld balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft is separated 29.7cm from the tip.There is tool marks on the shaft near the separation.The shaft is stretched 6.5cm from the tip.The balloon is torn circumferentially 2cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that may have contributed to the reported event.
Event or Problem Description
It was reported that stent inadequate apposition, balloon rupture and difficulty removal occurred.An express sd renal/biliary stent was advanced for treatment.However, during balloon expansion, the balloon ruptured and was not able to be removed from the stent after many tries.The stent was only expanded on the distal tip.Both the stent and balloon are still in the patient.Intervention is planned to remove both the stent and balloon.No further complications were reported.

• 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 MN ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 11657678
• Report Number: 2134265-2021-04572
• Device Sequence Number: 4224547
• Product Code: NIO
• UDI-Device Identifier: 08714729392095
• UDI-Public: 08714729392095
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2023
• 2 Devices were Involved in the Event: 1 2

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: 02/16/2023
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0025217763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 04/16/2021; 05/04/2023
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/05/2021; 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown