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

Model Number 26605

Device Problems Mechanical Problem (1384); Activation Failure (3270)

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

Event Date 07/21/2023

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

Event Description

It was reported that stent expansion failure occurred.An 8.0-21 carotid wallstent was advanced for treatment.However, when the stent was released, the distal end did not open.An attempt was made to recapture and released the stent, but the stent still will not open.Furthermore, the stent was recaptured for a second time aiming to change the stent but was unsuccessful.Consequently, the stent was released below the injury, and was impossible to return to its ideal position.A new 7x30 wallstent was open and deployed in its correct position.No patient complications were reported.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).Device evaluated by mfr.: carotid wallstent monorail 8.0-21 was received for analysis.A visual examination found the stent of the device to be fully deployed from the device.The deployed stent was not returned for analysis as it had been implanted inside the patient.A visual and tactile inspection identified no kinks or damage to the delivery system.There were no issues identified with the tip of the device.

Event Description

It was reported that stent expansion failure occurred.An 8.0-21 carotid wallstent was advanced for treatment.However, when the stent was released, the distal end did not open.An attempt was made to recapture and released the stent, but the stent still will not open.Furthermore, the stent was recaptured for a second time aiming to change the stent but was unsuccessful.Consequently, the stent was released below the injury, and was impossible to return to its ideal position.A new 7x30 wallstent was open and deployed in its correct position.No patient complications were reported.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17598613
• MDR Text Key: 321685739
• Report Number: 2124215-2023-42865
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0029397137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female