MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT¿; STENT, CAROTID

Model Number H965SCH647120

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).  device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.  (b)(4).

Event Description

It was reported that stent positioning/placement problem were encountered.The target lesion was located in the carotid artery.A 10.0-24 mm carotid wallstent¿ was advanced to treat the lesion.However, upon deployment, the stent would jumped.The procedure was completed with another of the same device.The patient complications were reported and the patient's status was stable.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7210287
• MDR Text Key: 97915527
• Report Number: 2134265-2018-00114
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: H965SCH647120
• Device Catalogue Number: SCH-64712
• Device Lot Number: 17641306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• 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