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 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that partial deployment occurred.The target lesion was located in the carotid artery.After dilation was performed with a non-bsc balloon catheter, a 10.0-24 carotid wallstent stent was advanced for treatment; however, only about 80% was deployed and the outer sheath got stuck.Since the stent could not be deployed while being stuck, the area of the stent that was already deployed and the guiding catheter was advanced over the deployed part of the stent for removal.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).E1 initial reporter city: (b)(6).Device evaluated by mfr: device was returned for analysis.A visual and tactile examination of the device identified an outer break at the proximal outer/middle outer bond.Middle outer bunching starting at the outer break point and extending 100mm distally was also identified.The device was returned with the stent partially deployed by 25mm.The stent was unable to be deployed due to the outer break.The stent deployed manually by 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

It was reported that partial deployment occurred.The target lesion was located in the carotid artery.After dilation was performed with a non-bsc balloon catheter, a 10.0-24 carotid wallstent stent was advanced for treatment; however, only about 80% was deployed and the outer sheath got stuck.Since the stent could not be deployed while being stuck, the area of the stent that was already deployed and the guiding catheter was advanced over the deployed part of the stent for removal.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• 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: 9811759
• MDR Text Key: 182737230
• Report Number: 2134265-2020-02499
• 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: 04/10/2020

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: 05/16/2023
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0024774934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: NIPRO ROADMASTER8F; GUIDE CATHETER: NIPRO ROADMASTER8F; GUIDEWIRE: ASAHI INTECC CHIKAI; GUIDEWIRE: ASAHI INTECC CHIKAI; KANEKA SHIDEN; KANEKA SHIDEN; GUIDE CATHETER: NIPRO ROADMASTER8F; GUIDEWIRE: ASAHI INTECC CHIKAI; KANEKA SHIDEN