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

Model Number 26605

Device Problems Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

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

Event Date 08/23/2021

Event Type  malfunction  

Event Description

It was reported that procedure cancellation occurred due to device problem.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left internal carotid artery.A 8.0-36 carotid wallstent was advanced for treatment with difficulty.Upon deployment, the physician felt the stent was stuck.When forcing the stent to release, the proximal shaft of the hub detached due to the effort needed to deploy the stent.The physician considered that the tortuous anatomy of the patient and the contact points of the stent sheath with the guiding catheter offered a lot of resistance to the stent release.The procedure was cancelled and reschedule.

Manufacturer Narrative

Device evaluated by mfr.: a carotid device was returned for analysis.A visual and tactile examination of the device identified outer break at the base of the t-connector.The outer had also detached from the shrink tubing.The device was returned with the stent fully mounted in the correct location on the device.The investigator was unable to deploy the stent due to the outer break.No issues were noted with the stent, stent holder or stent cups.A red blood like substance was observed in the device.There was a kink identified on the stainless-steel shaft 30mm distally from the distal end of the hub.A visual and microscopic investigation identified no issues with the tip that could have contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that procedure cancellation occurred due to device problem.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left internal carotid artery.A 8.0-36 carotid wallstent was advanced for treatment with difficulty.Upon deployment, the physician felt the stent was stuck.When forcing the stent to release, the proximal shaft of the hub detached due to the effort needed to deploy the stent.The physician considered that the tortuous anatomy of the patient and the contact points of the stent sheath with the guiding catheter offered a lot of resistance to the stent release.The procedure was canceled and rescheduled.

• 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: 12465721
• MDR Text Key: 271256654
• Report Number: 2134265-2021-11226
• 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: 10/22/2021

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 Expiration Date: 04/15/2024
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0026191222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR