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

Model Number 26605

Device Problems Positioning Failure (1158); Difficult to Remove (1528)

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

Event Date 04/15/2021

Event Type  malfunction  

Event Description

It was reported that removal difficulties were encountered.The moderately stenosed target lesion was located in the non-tortuous and non-calcified left internal carotid artery.A 10.0-31 carotid monorail stent self expanding was advanced for treatment.During deployment, the delivery system could not be withdrawn smoothly despite several attempts.The stent was fully reconstrained and removed from the patient's body.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.

Event Description

It was reported that removal difficulties was encountered.The moderately stenosed target lesion was located in the non-tortuous and non-calcified left internal carotid artery.A 10.0-31 carotid monorail stent self expanding was advanced; however, the stent catheter could not be withdrawn smoothly despite several attempts.The stent was fully reconstrained and removed from the patient's body.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.Updating reported event from "it was reported that removal difficulties was encountered" to "it was reported that the stent failed to deploy, but was reconstrained and simply removed".

Manufacturer Narrative

(b5) describe event or problem: updated.Device evaluation by mfr: the complaint device 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.No issues were identified during the product analysis.

• 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: 11785823
• MDR Text Key: 249460544
• Report Number: 2134265-2021-05525
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0026813805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 65