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

Model Number 26605

Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/20/2021

Event Type  Injury  

Event Description

It was reported that the stent reconstraining difficulties were encountered.The target lesion was located in the severely tortuous carotid artery.A 10.0-37 carotid wallstent was advanced for treatment.After the stent reached the lesion, the stent was partly deployed; however, it failed to exceed the recapture point and the stent was misplaced with delivery system inside the arteria carotis communis.Since the device failed to completely cover the lesion, the physician removed it all together and replaced it with another of the same device to complete the procedure.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.:carotid wallstent monorail 10.0-37 was received for analysis.The device was received with the stent in the correct position on the delivery system.The investigator successfully deployed the stent with no issues or resistance experienced.No damage was noted to the deployed stent.A visual inspection of the stent impression and stent cups identified no issues.The imprinted stent impression was clear on the stent holder.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues along the length of the device.

Event Description

It was reported that the stent reconstraining difficulties were encountered.The target lesion was located in the severely tortuous carotid artery.A 10.0-37 carotid wallstent was advanced for treatment.After the stent reached the lesion, the stent was partly deployed; however, it failed to exceed the recapture point and the stent was misplaced with delivery system inside the arteria carotis communis.Since the device failed to completely cover the lesion, the physician removed it all together and replaced it with another of the same device to complete the procedure.There were no patient complications reported and the patient status was stable.

• 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: 13002395
• MDR Text Key: 282217913
• Report Number: 2134265-2021-15432
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0023875333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2019
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 75 KG