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

Model Number H965SCH647120

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6) or older.(b)(4).

Event Description

It was reported that stent deployment issue occurred.The target lesion was located in the carotid artery.A 10.0-24 carotid wallstent¿ was advanced to treat the lesion.However, the stent was not fully deployed to the vessel wall.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: a visual examination of the returned device identified no kinks or damage which could potentially have contributed to the complaint incident.A recommended 0.014 inch guidewire was inserted through the wire lumen with no resistance noted.An examination of the inner and outer exit holes found no damage.As part of the device analysis the stent was fully deployed with no restriction.An examination of the deployed stent found no damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that stent deployment issue occurred.The target lesion was located in the carotid artery.A 10.0-24 carotid wallstent was advanced to treat the lesion.However, the stent was not fully deployed to the vessel wall.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5554266
• MDR Text Key: 42083409
• Report Number: 2134265-2016-02431
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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,Followup
• Report Date: 03/09/2016

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: 05/05/2016
• Device Model Number: H965SCH647120
• Device Catalogue Number: SCH-64712
• Device Lot Number: 15655561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2012
• 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