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

Model Number 26606

Device Problem Fracture (1260)

Patient Problems Stroke/CVA (1770); Foreign Body In Patient (2687)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).Implanted date: 2018.

Event Description

It was reported that a stent fracture and mild cerebral infarction occurred.The target lesion was located in the internal carotid and common carotid arteries.A 10.0-31 carotid wallstent monorail stent was implanted in 2018.During follow up, it was noticed that the distal part of the stent was fractured inside the patient.A mild cerebral infarction was noted, and a computerized tomography scan showed something white, as if something like a piece of metal was flying around.Additional information was requested and has not been received.No further patient complications were reported.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) general hospital.D6a: implanted date: 2018.Device eval.By manufacturer: the carotid device was not returned for analysis.However images of the stent were provided by the customer and were reviewed.From the images provided by the customer, it could not be positively confirmed that the stent was fractured; however it could be confirmed that the distal stent wires had been damaged.H3 other text : media.

Event Description

It was reported that stent fracture and mild cerebral infarction occurred.The target lesion was located in the internal carotid and common carotid arteries.A 10.0-31 carotid wallstent monorail stent was implanted in 2018.However, during follow up, it was noticed that the distal part of the stent was fractured inside the patient.A mild cerebral infarction was noted and the computerized tomography scan showed something white as if something like a piece of metal was flying around.No further patient complications were reported.

• 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 IRELAND LIMITED
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13655568
• MDR Text Key: 286494711
• Report Number: 2134265-2022-01813
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Male