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

Model Number 26605

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 21oct2021.It was reported that device difficulty advancing through sheath was encountered.The target lesion was located in carotid artery.A 8.0-29 carotid wallstent monorail stent was advanced for treatment.However, it was noted that the stent could not be delivered out of sheath when stent crossed the lesion through catheter.The procedure was completed with another of the same device.There were no patient complications reported and the patient was in stable condition.However, returned device analysis revealed stent damage and stent partial deployment.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned with a guidewire inserted in the device and with the stent partially deployed and stent struts damaged which were pulled in a proximal direction.A visual and tactile examination identified damaged to the outer shaft 31mm proximal from the distal markerband.The investigator was unable to insert the device into the sheath due to the partially deployed and damaged stent.No other issues were identified during the product analysis.

• 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: 12760096
• MDR Text Key: 280588312
• Report Number: 2134265-2021-13676
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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: 0026866160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 64 KG