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

Model Number 26606

Device Problems Entrapment of Device (1212); Fracture (1260); Material Separation (1562); Device-Device Incompatibility (2919)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that stent fracture and catheter entrapment occurred.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was implanted for treatment.A sterling balloon catheter was approached into the stent after implantation of the device for post- dilatation.However, a resistance was felt at the proximal, midline, and distal part of the stent.The ivus (opticross) was also used and resistance was also observed.It was attempted to lift the recovery sheath during recovery of the filterwire ez, however, it got stuck and could not be lifted.The physician managed to perform recovery while changing the guiding position.The inside of the guiding catheter was aspirated after recovering the filterwire ez, and a v-shaped metal fragment at the tip was recovered.The procedure was completed with the original device.No patient complications were reported.The patient is doing well.

Event Description

It was reported that a stent issue occurred.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was implanted for treatment.A sterling balloon catheter was approached into the stent after implantation of the device for post- dilatation.However, a resistance was felt at the proximal, midline, and distal part of the stent.The ivus (opticross) was also used and resistance was also observed.It was attempted to lift the recovery sheath during recovery of the filterwire ez, however, it got stuck and could not be lifted.The physician managed to perform recovery while changing the guiding position.The inside of the guiding catheter was aspirated after recovering the filterwire ez, and a v-shaped metal fragment at the tip was recovered.It was thought the fragment came from the stent.The procedure was completed with the original device.No patient complications were reported.The patient is doing well.

Manufacturer Narrative

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

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15396671
• MDR Text Key: 303279718
• Report Number: 2124215-2022-33792
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0029364047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• 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