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

Model Number H965SCH647120

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent positioning/placement issue occurred resulting to additional intervention.The 80% stenosed target lesion was located in the tortuous carotid artery.A 10.0-24 carotid wallstent¿ was advanced to treat the lesion.However, when the device reached the target lesion, the physician felt resistance at the distal portion of the shaft.When the stent was deployed, it was slightly displaced approximately 3mm than the intended lesion.Subsequently, the physician observed that the distal tip of the shaft was not normal under x-ray.To cover the missed portion of the target lesion, another of the same stent was then deployed and the procedure was completed.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

The device was returned with the stent fully deployed from the delivery system and was not returned for analysis.A full visual and microscopic examination was performed.Blood was noted on the inside and the outside of the device.The investigator measured the distance between the distal edge of the proximal markerb and the distal edge of the distal markerband to determine what size stent would have been mounted onto this delivery device.The distance was measured at 53mm in length.The measurement of 53mm is within specification.A full visual and microscopic examination of this device identified no issues with the shaft, stent cups, stent holder or tip that could have contributed to the complaint incident.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that stent positioning/placement issue occurred resulting to additional intervention.The 80% stenosed target lesion was located in the tortuous carotid artery.A 10.0-24 carotid wallstent was advanced to treat the lesion.However, when the device reached the target lesion, the physician felt resistance at the distal portion of the shaft.When the stent was deployed, it was slightly displaced approximately 3mm than the intended lesion.Subsequently, the physician observed that the distal tip of the shaft was not normal under x-ray.To cover the missed portion of the target lesion, another of the same stent was then deployed and the procedure was completed.No patient complications were reported and the patient's status was stable.

• 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: 7032630
• MDR Text Key: 92043238
• Report Number: 2134265-2017-11466
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2020
• Device Model Number: H965SCH647120
• Device Catalogue Number: SCH-64712
• Device Lot Number: 20082253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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
• Patient Outcome(s): Required Intervention