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

Model Number 26606

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: over 18 years old.(b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination of the device identified outer/handle break 168mm distal from the distal end of the hub.The outer had detached from the shrink tubing.The investigator was unable to deploy the stent due to the outer break.The investigator deployed the stent manually by cutting through the distal outer and pulling the tip while gripping the outer.No issues were noted with the stent, stent holder or stent cups.A red blood like substance was observed in the device.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

Reportable based on device analysis completed on 22-apr-2020.It was reported that stent difficult to deploy occurred.The target lesion was located in the moderately tortuous common carotid artery to internal carotid artery (ic).After a filterwire was placed at the distal part of ic, a 10.0-31 carotid wallstent stent was advanced for treatment.However, during the procedure, the stent could not be deployed due to defective outer sheath.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed an outer/handle break.

• 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: 10009653
• MDR Text Key: 189625597
• Report Number: 2134265-2020-05713
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0024997689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• 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