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

Model Number 26605

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  Injury  

Event Description

It was reported that the stent would not expand, requiring additional intervention.An 8mm x 29mm carotid wallstent was selected for use in an percutaneous transluminal angioplasty procedure in the right internal carotid artery.The 90% stenosed target lesion was not calcified.An 8f guide catheter and a filterwire ez embolic protection system were used.During the procedure, an attempt was made to deploy the stent, but it would not expand and oppose to the distal end of the vessel wall.The vessel was post-dilated, but the stent still did not expand.Another stent was used to wall oppose the stent and complete the procedure.No patient complications were reported, and the patient was in fine condition post-procedure.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10941879
• MDR Text Key: 219493441
• Report Number: 2134265-2020-16866
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2024
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0025696525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR