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

Model Number	20226
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device eval by manufacturer: the device was returned with the stent detached from the balloon.The customer's 6fr introducer sheath was returned for analysis with the stent of the returned device inside it.The recommended sheath size as per dfu for this express device is a 6fr introducer sheath.The balloon was noted to be tightly folded and had not been subjected to positive pressure.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.The rate of burst pressure of this express ld device is 12atm (atmospheres).The device was returned with the stent detached the balloon.The stent was returned inside the customers introducer sheath.The investigator removed the stent from the sheath.A visual and microscopic examination identified that the first row of the distal stent struts was damaged.The first four rows of the proximal were also noted to be compressed.This type of damage is consistent with excessive force being applied to the stent.No other issues were identified with the stent that could potentially have contributed to the complaint incident.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 stretching on the shaft of the device beginning approximately 4mm proximal of the proximal balloon bond and extending approximately 4mm proximately down the shaft.This type of damage is consistent with excessive tensile force being applied when attempting to remove the device.No other issues were identified with the shaft that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the stent dislodged.A 8.0x30x135cm express ld iliac / biliary stent was selected for use to treat the lesion within the iliac artery.During introduction outside the patient, the device became stuck when entering the 6f sheath and the stent struts were found detached from the balloon after removal.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Aware date is being corrected from 13dec2018 to 16jan2019.Age at time of event: 18 years or older.Device eval by manufacturer: the device was returned with the stent detached from the balloon.The customer's 6fr introducer sheath was returned for analysis with the stent of the returned device inside it.The recommended sheath size as per dfu for this express device is a 6fr introducer sheath.The balloon was noted to be tightly folded and had not been subjected to positive pressure.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.The rate of burst pressure of this express ld device is 12atm (atmospheres).The device was returned with the stent detached the balloon.The stent was returned inside the customers introducer sheath.The investigator removed the stent from the sheath.A visual and microscopic examination identified that the first row of the distal stent struts was damaged.The first four rows of the proximal were also noted to be compressed.This type of damage is consistent with excessive force being applied to the stent.No other issues were identified with the stent that could potentially have contributed to the complaint incident.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 stretching on the shaft of the device beginning approximately 4mm proximal of the proximal balloon bond and extending approximately 4mm proximately down the shaft.This type of damage is consistent with excessive tensile force being applied when attempting to remove the device.No other issues were identified with the shaft that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the stent dislodged.A 8.0x30x135cm express ld iliac / biliary stent was selected for use to treat the lesion within the iliac artery.During introduction outside the patient, the device became stuck when entering the 6f sheath and the stent struts were found detached from the balloon after removal.The procedure was completed with another of the same device.No 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: 8331352
• Report Number: 2134265-2019-00211
• Device Sequence Number: 1650312
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• 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): 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022734275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1