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

Model Number H965SCH647080

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(6) 2015.It was reported that crossing difficulties were encountered.The non totally occluded, eccentric, de novo target lesion was located in the mildly calcified carotid artery.After a 205cm non bsc guidewire crossed the lesion, the physician stented the distal carotis interna with a 7x50 carotid wallstent.The physician needed a second stent to covert the bifurcation and the distal carotis communis.A 8.0-29 carotid wallstent¿ was advanced to treat the lesion but there was resistance and failed to cross the previously placed stent.The physician saw that the stent did not cover the distal 1mm with the delivery sheath.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.However, returned device analysis revealed stent damage.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device was received for analysis.A visual and microscopic examination confirmed that the distal stent wires were uncrossed.This damage is consistent with the device encountering an obstruction during the advancement of the device.There were no issues noted with the profile of the tip.The tip od was measured and is within specification.The stent was partially deployed by 4mm.No issues were noted with the balloon profile.The balloon wings were tightly wrapped, evenly folded and the balloon was not subjected to positive pressure.A visual and tactile examination found no kinks or damage along the shaft of the device.The delivery system od was measured and is within specification.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 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: 4504569
• MDR Text Key: 20374066
• Report Number: 2134265-2015-00480
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: H965SCH647080
• Device Catalogue Number: SCH-64708
• Device Lot Number: 16239421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2013
• 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: GUIDEWIRE: TRANSEND EX 205CM (STRYKER)