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

Model Number H965SCH647090

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.  (b)(4).

Event Description

It was reported that the stent detached from its delivery system.The target lesion was located in the carotid artery.An 8.0-36 carotid wallstent¿ was advanced to treat the lesion.However, during the procedure, the stent detached from its delivery system.The device was completely removed from the patient with the use of a snare catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the carotid device was returned with the stent fully deployed from the delivery system.A visual and tactile examination of the device identified no issues or any damage along the length of the catheter that could have contributed to the complaint incident.A visual and microscopic examination of the deployed stent identified no damage or any issues with the deployed stent that could have contributed to the complaint incident.A visual and microscopic investigation identified no issues with the stent cups, stent holder or tip that could have contributed to the complaint incident.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 investigation conclusion was unable to be determined.(b)(4).

Event Description

It was reported that the stent detached from its delivery system.The target lesion was located in the carotid artery.An 8.0-36 carotid wallstent¿ was advanced to treat the lesion.However, during the procedure, the stent detached from its delivery system.The device was completely removed from the patient with the use of a snare catheter.The procedure was completed with another of the same device.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: 7013421
• MDR Text Key: 91452381
• Report Number: 2134265-2017-11053
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2020
• Device Model Number: H965SCH647090
• Device Catalogue Number: SCH-64709
• Device Lot Number: 20550690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2017
• 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
• Patient Outcome(s): Required Intervention