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

Model Number 26605

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem Ischemia Stroke (4418)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

It was reported that the stent could not be deployed and a cerebral infarction occurred.The target lesion was located in the carotid artery.A 8.0-36 carotid wallstent was advanced for treatment.However, when deploying the stent, the distal part deployed normally but the proximal end failed.After multiple attempts, the whole system including the filterwire were removed from the body.After withdrawal, the stent was pulled into the y valve.The procedure was not completed due to this event in which the patient had a cerebral infarction.Post ischemic infarction, the patient accepted a conservative treatment.Following the procedure, the patient had another surgery.There were no patient complications reported.

Event Description

It was reported that the stent could not be deployed and a cerebral infarction occurred.The target lesion was located in the carotid artery.A 8.0-36 carotid wallstent was advanced for treatment.However, when deploying the stent, the distal part deployed normally but the proximal end failed.After multiple attempts, the whole system including filterwire was removed from the patients body.After withdrawal, the stent was pulled into the y valve.The procedure was not completed due to this event in which the patient had a cerebral infarction.Post ischemic infarction, the patient accepted a conservative treatment.Following the procedure, the patient had another surgery.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.Device eval by mfr: a carotid device was received for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent deployed form the delivery system.No damage or issues were noted with the deployed stent.This concludes the product analysis.

• 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: 14358924
• MDR Text Key: 291402270
• Report Number: 2134265-2022-04732
• 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: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0026971612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG