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

Model Number H965SCH647080

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This carotid device is recommended for use with a 5f introducer sheath as per carotid monorail product specification.During the product analysis, the device was successfully advanced through a boston scientific 5f introducer sheath.No resistance or issues were encountered.A visual and microscopic examination found the stent to be partially deployed.The proximal stent wires were noted to be exposed and bent.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues along the length of the device.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2018.It was reported that stent partial deployment and difficulty advancing through introducer sheath were encountered.The target lesion was located in the carotid artery.An 8.0-29 carotid wallstent was selected for use to treat the lesion.However, the tip of the stent had opened partially deployed and could not be inserted into the introducer sheath.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.

• 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: 7358862
• MDR Text Key: 103089729
• Report Number: 2134265-2018-01921
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2020
• Device Model Number: H965SCH647080
• Device Catalogue Number: SCH-64708
• Device Lot Number: 20736892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• 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 Age: 40 YR