MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number 26606

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Event Description

It was reported that the stent delivery system became stuck on the filterwire.The target lesion was located in mildly tortuous internal carotid artery (ica).A 190cm filterwire ez and carotid wallstent were selected for use.Access was obtained from the femoral artery and the filterwire was placed in the distal ica.During procedure, it was noted that resistance was felt at the mid side of the carotid wallstent guidewire lumen when the stent was delivered.The stent was placed in the lesion.During removal, the stent delivery system became entrapped with the filterwire at the same location of the previous resistance.The devices were completely removed as a unit.The procedure was completed.No patient complications were reported and patient's condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The used carotid device was returned with the stent already deployed.The stent was not returned with the device.Multiple outer kinks were also observed on the returned device.Model number updated to 26606.Lot number updated to 0022535961.Catalog number updated to 26606.Expiration date updated to 02/18/2022.Unique identifier (udi)# updated to (b)(4).Device manufacture date updated to 08/20/2018.

Event Description

It was reported that the stent delivery system became stuck on the filterwire.The target lesion was located in mildy tortuous internal carotid artery (ica).A 190cm filterwire ez and carotid wallstent were selected for use.Access was obtained from the femoral artery and the filterwire was placed in the distal ica.During procedure, it was noted that resistance was felt at the mid side of the carotid wallstent guidewire lumen when the stent was delivered.The stent was placed in the lesion.During removal, the stent delivery system became entrapped with the filterwire at the same location of the previous resistance.The devices were completely removed as a unit.The procedure was completed.No patient complications were reported and patient's condition was good.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8678465
• MDR Text Key: 147319860
• Report Number: 2134265-2019-06511
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0022535961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1