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

Model Number 26606

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2020

Event Type  malfunction  

Event Description

It was reported that reconstraining difficulties were encountered.The target lesion was located in the internal carotid artery.A 10.0-31 carotid monorail was advanced to treat the lesion.However, in an attempt to re-sheath the stent for better positioning, the stent could not be reconstrained.The device was able to be removed and it was noticed that the outer sheath was damaged.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was received with the stent partially deployed on the delivery system.The stent could not be fully constrained due to a complete break in the outer shaft of the device and solidified media inside the delivery system.The distal stent wires were also noted to be damaged.A visual and tactile inspection identified a complete break of the outer shaft located approximately 60mm distal of the main valve.This type of damage is consistent with excessive tensile 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

It was reported that reconstrain difficulty occurred.A 10.0-31 carotid monorail was selected for use.When physician tried to re-sheath to adjust the placement position, he experience a very difficult to re-sheath.The re-sheath was managed to be resealed to a level where removal was possible, so the device was removed.However, the outer sheath of the removed device was damaged.The procedure was completed with another of same device.There were no patient complications reported.It wa further reported that the target lesion was moderately tortuous.

• 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: 10770884
• MDR Text Key: 214123463
• Report Number: 2134265-2020-15049
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0025571554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1