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

Model Number H965SCH647070

Device Problems Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that partial stent deployment occurred and stent recapturing difficulties were encountered.The target lesion was located in the carotid artery.After a.014 non-bsc guidewire crossed the lesion, an 8.0-21 carotid wallstent¿ was advanced for treatment.However, when the device was advanced through the arch of the aorta, the device encountered difficulties tracking over the guidewire.It was then observed under fluoroscopy that the tip of the stent was deployed about 5mm.The physician attempted to pull back the stent into the sheath however, about 2mm of the stent was still out of the sheath.The device was then fully withdrawn into the guide catheter.The device was completely removed from the patient and the procedure was completed with a different device.The physician deployed the stent outside the patient's body.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned with the stent deployed from the delivery system.The customer¿s guidewire was not returned for analysis.A visual and tactile examination on the shaft identified one severe kink at the distal markerband of the device.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft that could have contributed to the compliant incident.This carotid device is recommended for use with a 0.014¿ (0.36mm) guidewire as per dfu.During the product analysis a boston scientific 0.014¿ guidewire was inserted through this device without any resistance or issue noted.No issues were identified that could have contributed to the complaint incident.A visual and microscopic examination of the deployed stent identified no issues 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 not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was further reported that the target lesion was approximately 90% stenosed located in the moderately tortuous and moderately calcified lesion.It was also further reported that the stent was deployed outside the patient's body.

• 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: 7007433
• MDR Text Key: 92179335
• Report Number: 2134265-2017-10578
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2020
• Device Model Number: H965SCH647070
• Device Catalogue Number: SCH-64707
• Device Lot Number: 0020664599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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