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

Model Number 26605

Device Problems Mechanical Problem (1384); Premature Activation (1484); Positioning Problem (3009)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).

Event Description

It was reported that the stent was difficult to position, difficult to reconstrain, and partially deployed.The 90% stenosed, and 4.9mmx15mm target lesion with soft plaque and calcification was located in the tortuous left internal carotid artery.A 18.0-21 carotid wallstent was advanced along the guide catheter to reach the lesion for treatment.When two-thirds of the stent was deployed, it migrated down lower than the lesion.During withdrawal, part of the stent could not be completely recaptured and was exposed when retracting into the sheath.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient status was stable.

Event Description

It was reported that the stent was difficult to position, difficult to reconstrain, and partially deployed.The 90% stenosed, and 4.9mmx15mm target lesion with soft plaque and calcification was located in the tortuous left internal carotid artery.A 18.0-21 carotid wallstent was advanced along the guide catheter to reach the lesion for treatment.When two-thirds of the stent was deployed, it migrated down lower than the lesion.During withdrawal, part of the stent could not be completely recaptured and was exposed when retracting into the sheath.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient status was stable.It was further reported that the stent was dislodged inside patient's body.The stent was intact on the delivery system and was removed with the guiding catheter.The stent may have remained in the guiding catheter and was discarded by the hospital.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr.: the carotid was returned for analysis.A visual and tactile examination identified no issues with the shaft of the device.The device was returned with the stent already deployed from the delivery system.The deployed stent was not returned with the device.H6 - device codes: added premature activation.

• 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: 18969549
• MDR Text Key: 338674382
• Report Number: 2124215-2024-17150
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 0030057438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• 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 Age: 60 YR