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

Model Number H965SCH647080

Device Problems Failure to Capture (1081); Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was received with the stent partially deployed from the device.An attempted to deploy the stent was made but was unsuccessful due to a complete break of the outer shaft located approximately 31mm distal of the main valve and a severe kink on the shaft located approximately 15mm distal of the guidewire port.This type of damage is consistent with excessive force being applied to the device when attempting to deploy the stent.A visual and tactile examination identified no issues with the tip of the device.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on the product analysis completed on august 10, 2018.It was reported the stent was unable to deploy.The 75% stenosed, target lesion was located in a highly tortuous arotic arch in the left "aci", a non bsc sheath and a 0.14 non bsc guidewire were placed.The stent was prepped with no difficulties and advanced over the wire, through the sheath, to the lesion.The stent was secured in place and then released.It could only be released a third of the stent and it couldn't be advanced or repositioned.The physician advanced the sheath over the entire length and then pulled the stent back into the sheath without further issues.The procedure was completed with a 9.5 carotid wallstent and everything went perfect.The patient was reported to be fine.However, the returned product analysis revealed that the stent was partially deployed.It was further reported the stent was unable to be re-sheathed and was removed from the patient with a third of the stent still partially deployed.

• 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: 7847179
• MDR Text Key: 119334986
• Report Number: 2134265-2018-07385
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• 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: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: H965SCH647080
• Device Catalogue Number: SCH-64708
• Device Lot Number: 0021083614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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: 60 YR