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

Model Number 20226

Device Problems Entrapment of Device (1212); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2020

Event Type  malfunction  

Event Description

It was reported that catheter entrapment occurred.The target lesion was located in the common iliac vessel.An 8.0x40x75cm express ld stent was advanced to treat the lesion.However, the device became stuck with the wire.Both devices were removed together from the patient's body.The wire would not retract from the lumen until pulled forcefully after removal from the body.It was noticed that the catheter of the stent looked oddly discolored and thinned.The procedure was completed with another express ld stent with a different guide wire.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: express ld device - 8x40x75cm was returned for analysis.The recommended size of guidewire for this device is 0.035 in.(0.89 mm).The guidewire used by the customer was not returned for analysis.A visual and microscopic examination identified that the stent had been moved to position that was approximately 5mm distal of the proximal markerband.A microscopic examination found damage to the first row of both proximal and distal stent struts of the displaced stent.No other issues were identified with the stent that could potentially have contributed to the complaint incident.A visual examination identified that the balloon had been not subjected to positive pressure.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.A visual and tactile examination identified severe stretching/ damage to the shaft of the device at more than one location.This type of damage is consistent with excessive tensile force being applied to the device.A visual and microscopic examination identified no issues with the tip of the device during analysis that could have contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that catheter entrapment occurred.The target lesion was located in the common iliac vessel.An 8.0x40x75cm express ld stent was advanced to treat the lesion.However, the device became stuck with the wire.Both devices were removed together from the patient's body.The wire would not retract from the lumen until pulled forcefully after removal from the body.It was noticed that the catheter of the stent looked oddly discolored and thinned.The procedure was completed with another express ld stent with a different guide wire.No patient complications were reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10536585
• MDR Text Key: 207025276
• Report Number: 2134265-2020-12749
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392279
• UDI-Public: 08714729392279
• Combination Product (y/n): N
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022634409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1