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

Model Number H965SCH647130

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that constrainment difficulties were encountered.A carotid wallstent¿ 10x31 was selected to treat the lesion located in the carotid artery.During deployment the wallstent¿ did not completely deploy.In attempts to reconstrain the partially deployed stent, the stent was not completely recaptured and was removed from the patient partially deployed.No patient complications were reported and the procedure was completed with another same device.

Manufacturer Narrative

Updated: method codes.Device evaluated by manufacturer: the manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.(b)(4).

Event Description

It was reported that re-constrainment difficulties were encountered.A carotid wallstent¿ 10x31 was selected to treat the lesion located in the carotid artery.During deployment the wallstent¿ did not completely deploy.In attempts to re-constrain the partially deployed stent, the stent was not completely recaptured and was removed from the patient partially deployed.No patient complications were reported and the procedure was completed with another same device.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned to the complaint investigation site with the stent fully mounted onto the delivery system.During analysis the investigator deployed the stent with no resistance noted.The stent fully expanded and the investigator identified no issues with the stent that could have contributed to the complaint incident.A visual and microscopic investigation of the stent cup/stent hoder identified no issues with the stent cup or stent holder that could have contributed to the complaint incident.A visual and tactile examination of the catheter profile found no kinks or other damage along the length of the catheter.No other issues were identified during the product analysis.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 reported that reconstrainment difficulties were encountered.A carotid wallstent 10x31 was selected to treat the lesion located in the carotid artery.During deployment the wallstent did not completely deploy.In attempts to reconstrain the partially deployed stent, the stent was not completely recaptured and was removed from the patient partially deployed.No patient complications were reported and the procedure was completed with another same device.

• 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: 7140025
• MDR Text Key: 95731487
• Report Number: 2134265-2017-12999
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Model Number: H965SCH647130
• Device Catalogue Number: SCH-64713
• Device Lot Number: 0021094351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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