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

Model Number 26605

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.The patient underwent carotid artery stent placement, puncture was performed via right femoral artery, guidewire and sheath were placed.Along the sheath, a hydrophilic guidewire and a vertebral artery imaging catheter were advanced into the internal carotid artery for angiography.After identifying the location of the lesion, a 14 unspecified guidewire was exchanged, and an 8f mach 1 guiding was placed at the ostial of bifurcation for support.Then a filterwire was advanced and deployed.Afterwards, a 4*30 rx balloon was used for pre-dilation.Then an 8.0-36 carotid monorail stent was prepared.Due to severe calcification in the blood vessel, stenosis of the lesion, and over-tortuosity of the blood vessel, after the stent entered, the catheter was kinked, and difficulty was encountered to deliver the stent.The physician pushed with force, but still could not reach the target position.The stent had to be removed.It was noted that the tip of the stent was severely damaged and could not be advanced unless with great force.For safety concern, the physician decided to use another stent, and the procedure was completed.No patient complications were reported, and the patient was stable.

Manufacturer Narrative

E1: (b)(6).Device evaluated by mfr: a carotid device was returned for analysis.A visual and tactile examination of the catheter/delivery system identified damage to the outer sheath, located 2 mm distal from the exchange port.The device was returned with the stent deployed from the delivery system.The deployed stent was not returned with the device.

Event Description

It was reported that stent damage occurred.The patient underwent carotid artery stent placement, puncture was performed via right femoral artery, guidewire and sheath were placed.Along the sheath, a hydrophilic guidewire and a vertebral artery imaging catheter were advanced into the internal carotid artery for angiography.After identifying the location of the lesion, a 14 unspecified guidewire was exchanged, and an 8f mach 1 guiding was placed at the ostial of bifurcation for support.Then a filter wire was advanced and deployed.Afterwards, a 4*30 rx balloon was used for pre-dilation.Then an 8.0-36 carotid monorail stent was prepared.Due to severe calcification in the blood vessel, stenosis of the lesion, and over-tortuosity of the blood vessel, after the stent entered, the catheter was kinked, and difficulty was encountered to deliver the stent.The physician pushed with force, but still could not reach the target position.The stent had to be removed.It was noted that the tip of the stent was severely damaged and could not be advanced unless with great force.For safety concern, the physician decided to use another stent, and the procedure was completed.No patient complications were reported, and the patient was stable.

• 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: 17618841
• MDR Text Key: 321918732
• Report Number: 2124215-2023-41622
• 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,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• 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: 0029602998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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
• Treatment: BALLOON CATHETER: 4*30 RX.; BALLOON CATHETER: 4*30 RX.; GUIDE CATHETER: 8F MACH 1.; GUIDE CATHETER: 8F MACH 1.
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 66 KG