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

Model Number 26606

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: an 8.0-29 carotid wallstent was returned for analysis.The device was received with the stent partially deployed on the delivery system.The stent could not be deployed due to a complete break of the outer shaft and solidified blood and media inside the delivery system.A visual and tactile inspection identified a complete break of the shaft of the device located approximately 180mm proximal of the guidewire port.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 24-jul-2020.It was reported that stent partial deployment occurred.The target lesion was located in the internal carotid artery.After an embolic protection device was placed and pre-dilatation was performed, an 8.0-29 carotid wallstent was advanced for treatment.However, during stent deployment, the stent was partially deployed and was unable to expand due to the strong resistance.Temporarily, it was re-sheathed and after induction was performed again, it was deployed but the condition was the same.The procedure was completed with another of the same device.No patient complications nor injuries reported.However, returned device analysis revealed the stent was partially deployed and there was a shaft 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: 10356251
• MDR Text Key: 201868826
• Report Number: 2134265-2020-10282
• 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: 08/03/2020

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: 09/11/2023
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0025349056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• 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