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

Model Number M001719020

Device Problem Difficult to Flush (1251)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the device was returned for analysis.The device was returned with the stent partially deployed by 2mm.A protruding wire was observed on the partially deployed unit on the distal side of the stent.There was damage identified to the stent.During the product analysis, the device was flush without issue.A visual and tactile examination found no kinks or other damage along the length of the catheter.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Reportable based on device analysis completed on 27-nov-2015.It was reported that difficulty flushing occurred.A 8x29, 5f, 135cm carotid wallstent was selected for use to treat the lesion.However, during preparation, the physician could not flush the lumen.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed partial stent deployment and 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5283504
• MDR Text Key: 33106998
• Report Number: 2134265-2015-08677
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2016
• Device Model Number: M001719020
• Device Catalogue Number: 71-902
• Device Lot Number: 15503999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2015
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2012
• 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