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

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2022

Event Type  Injury  

Event Description

It was reported that the overlapping stents migrated and a new stent was placed in between.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified vein.A 10x31mm carotid wallstent was selected for use.During the procedure, dilatation was performed with a 3.0x20mm sterling balloon and the 10x31mm carotid wallstent was deployed.The distal vessel with the deployed stent was severely tortuous and an 8x21mm carotid wallstent was then placed to overlap the first carotid wallstent by 5mm.Contrast with 5x20mm sterling balloon was then used for post dilation.Afterwards, it was noted that the stents migrated and were no longer overlapped.A third carotid wallstent was used, and it was placed in between the two placed stents to complete the procedure.No further patient complications were reported.

• 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: 14518286
• MDR Text Key: 292795878
• Report Number: 2134265-2022-05735
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female