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

Model Number H965SCH647070

Device Problems Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that stent inadvertent deployment occurred.A 8.0-21 carotid wallstent¿ was selected for use to treat a lesion.However, during unpacking of the device, it was noted that the stent was dislodged.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the stent was fully constrained on the returned device.The investigator deployed the stent without issue.The deployed stent was visually inspected with no issues noted.A visual and tactile inspection identified no issues along the length of the device.No 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

It was reported that stent inadvertent deployment occurred.A 8.0-21 carotid wallstent¿ was selected for use to treat a lesion.However, during unpacking of the device, it was noted that the stent was dislodged.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 6176603
• MDR Text Key: 62470848
• Report Number: 2134265-2016-11474
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2017
• Device Model Number: H965SCH647070
• Device Catalogue Number: SCH-64707
• Device Lot Number: 16341155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2013
• 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