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

Model Number 26605

Device Problems Difficult to Advance (2920); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual examination found the stent to be mounted in the correct position on the delivery system.A visual and tactile inspection identified complete break of the outer shaft of the device located at the guidewire port.The inner shaft was also noted to be severely kinked at the site of the outer shaft break.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 06mar2020.It was reported that inadvertent deployment and advancing difficulties were encountered.Vascular access was obtained via the femoral artery.The 90% stenosed, 25x7mm, concentric, de novo target lesion was located in the moderately tortuous and lowly calcified right coronary artery.Pre-dilation was performed with a 2.5x20mm emerge balloon catheter, leaving 60% stenosis.A 8.0-29mm carotid monorail stent was advanced but had difficulty advancing.It was deployed but removed from the patient.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.However, returned device analysis revealed shaft detach/separate.

• 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: 9860520
• MDR Text Key: 184307069
• Report Number: 2134265-2020-03572
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2020

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: 06/20/2022
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0023112338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• 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