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

Model Number H965SCH647140

Device Problems Bent (1059); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The 85% stenosed, 50mm x 9mm, eccentric, de novo target lesion was located in the non-tortuous and non-calcified right internal carotid (right ica) artery.An unspecified size non-bsc guide catheter and non-bsc guidewire were advanced towards the target vessel.Subsequently, a 10.0-37 carotid wallstent¿ was selected for use and advanced but failed to cross the lesion.The device was removed and the physician noted that there was deformation at the end of the stent.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.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).

• Brand Name: CAROTID WALLSTENT?
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4260108
• MDR Text Key: 5017041
• Report Number: 2134265-2014-06987
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2017
• Device Model Number: H965SCH647140
• Device Catalogue Number: SCH-64714
• Device Lot Number: 16683062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• 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
• Treatment: JR- GUIDE CATHETER; RINATO- GUIDE WIRE
• Patient Age: 75 YR