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

Model Number H965SCH647090

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned with the stent fully mounted onto the delivery system.A visual and tactile examination on the shaft identified one severe kink 6mm proximal to the tip of the device.The kink was so severe it extended down through the mounted stent into the inner shaft of the device.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the inner or outer shaft that could have contributed to the compliant incident.The stent was returned in the correct position on the delivery system.The distal end of the mounted shaft was noted to be damaged due to the severe shaft kink.During analysis the investigator successfully deployed the stent without any resistance or issues noted.A visual and microscopic examination identified that the struts of the distal section of the device where damaged.This damage was caused by the severe kink identified on the shaft of the device.No issues were noted with the stent that could have contributed to the complaint incident.A visual and microscopic examination identified no damage or any issues with the stent cups, stent holder or tip of the device that could have contributed to the complaint incident.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 device analysis completed on 14nov2017.It was reported that stent failed to deploy.Vascular access was obtained via the brachial artery.The 12mm x 10mm target lesion was located in the non-tortuous and non-calcified carotid artery.A 8.0-36mm carotid wallstent¿ was advanced to treat the lesion.However, the stent was unable to deploy from the delivery system.The physician reconstrain the stent prior to removal of the device.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 damaged.

• 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: 7083529
• MDR Text Key: 94503327
• Report Number: 2134265-2017-11751
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2020
• Device Model Number: H965SCH647090
• Device Catalogue Number: SCH-64709
• Device Lot Number: 19744567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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