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

Model Number H965SCH647120

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the carotid artery.A 10.0-24 carotid wallstent¿ was selected to treat the lesion.The physician used two 0.14 190cm filterwire guide wires to advanced the stent.Resistance was felt and the stent was damage when expanding.The device was removed safely and another wallstent¿was used without problem.No patient complications were reported and the patient's status was fine and stable.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was returned for analysis.The stent could not be deployed by pushing on the handle due to the multiple kinks and solidified blood on the device.The clear shrink tube was detached from the t-connector and bunching was observed 85mm distal of the point of no return mark on the stainless steel handle.This type of damage is consistent with the application of excessive force to the delivery system.The stent was deployed manually by pulling back the tip and inner while holding onto the outer.The stent and a section of inner immediately detached from the device due to the damage inflicted during the procedure.The stent did not fully expand due to solidified blood.The stent was soaked in a water bath at a temperature of 37 degrees to help soften the solidified blood.Stent expanded without issue.There were no issues noted with the profile of the stent.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the carotid artery.A 10.0-24 carotid wallstent was selected to treat the lesion.The physician used two 0.14 190cm filterwire guide wires to advanced the stent.Resistance was felt and the stent was damage when expanding.The device was removed safely and another wallstent was used without problem.No patient complications were reported and the patient's status was fine and stable.

• 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: 5210687
• MDR Text Key: 30726335
• Report Number: 2134265-2015-07505
• 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,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2017
• Device Model Number: H965SCH647120
• Device Catalogue Number: SCH-64712
• Device Lot Number: 16315988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2013
• 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