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

Model Number 26605

Device Problems Difficult or Delayed Positioning (1157); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: device was returned for analysis.A visual and microscopic examination was performed on the returned device.The device was returned with the deployment handle fully pushed forward.A visual and tactile examination identified a complete break in the outer shaft of the device approximately 1190mm distal to the t connector.Multiple severe kinks were also noted on the inner shaft of the device.This outer shaft break prevented deployment and of the stent as the inner shaft could not be pushed forward to allow for deployment.No issues were noted with the catheter that could have contributed to the damage identified.The damage identified is consistent with excessive force being applied to the delivery system.A visual and microscopic examination was performed on the tip and markerbands of the device.No damage or any issues were noted that could have contributed to the complaint incident.The stent was returned fully mounted onto the delivery system.A visual and microscopic examination of the crimped stent identified no stent damage.Due to the condition of the returned device the stent could not be deployed.No issues were noted with the stent 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 25-sep-2019.It was reported that advancing difficulties were encountered and stent deployment failure occurred.The target lesion was located in the right internal carotid artery.After a 190 cm filterwire ez was positioned, pre-dilatation was performed with a balloon.A 10.0-37 carotid wallstent was advanced but failed to pass through the lesion.The wire sheath of the filterwire was bent as the shuttle sheath was pulled towards the aorta.After that, the carotid stent passed through the lesion with difficulty but could not be deployed.The device was removed and the procedure was then completed with a 9-40 carotid wallstent.No patient complications were reported.However, returned device analysis revealed shaft detachment.

• 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: 9180317
• MDR Text Key: 163158447
• Report Number: 2134265-2019-12238
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 10/10/2019

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 Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0024046747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• 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
• Patient Age: 82 YR