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

Model Number 26605

Device Problems Positioning Failure (1158); Premature Activation (1484); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Event Description

It was reported that the stent inadvertently deployed.Vascular access was obtained via femoral artery with an 8f sheath.The 90% stenosed target lesion was located in the right internal carotid artery.After a filter was placed through an 8f guide catheter and predilatation was performed with a 4x30 sterling balloon catheter, a 8.0-21 carotid monorail stent was selected for use, but could not be advanced smoothly.The physician tried several times but the stent could not deploy.During withdrawal, stent dislodgement occurred.The stent itself was deployed inside the catheter.The physician removed the stent with the catheter without any intervention and the procedure was completed with another of the same device.No patient complications were reported, and the patient status was stable.

Manufacturer Narrative

Device evaluation by mfr: a visual examination found that the stent of the device had been deployed from the delivery system.The stent was not returned for analysis.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 other issues were identified during the product analysis.

Event Description

It was reported that the stent inadvertently deployed.Vascular access was obtained via femoral artery with an 8f sheath.The 90% stenosed target lesion was located in the right internal carotid artery.After a filter was placed through an 8f guide catheter and predilatation was performed with a 4x30 sterling balloon catheter, a 8.0-21 carotid monorail stent was selected for use but could not be advanced smoothly.The physician tried several times but the stent could not deploy.During withdrawal, stent dislodgement occurred.The stent itself was deployed inside the catheter.The physician removed the stent with the catheter without any intervention and the procedure was completed with another of the same device.No patient complications were 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
• MDR Report Key: 10919074
• MDR Text Key: 218705607
• Report Number: 2134265-2020-16567
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0025347567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER USED: STERLING; BALLOON CATHETER USED: STERLING; BALLOON CATHETER USED: STERLING
• Patient Age: 62 YR
• Patient Weight: 59