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

Model Number H965SCH647120

Device Problems Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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 the stent was explanted.The target lesion was located in a severely calcified left vertebral artery.A 10.0-24mm carotid wallstent¿ was implanted in the left subclavian artery.A 4.0mmx19mmx150cm express¿ vascular sd stent was advanced but failed to deployed due to severe calcification.Then the express sd delivery system was withdrawn; however, the wallstent¿ became explanted during removal of the stent delivery systm.The procedure was completed with a different device.No further patient complications were reported and the patient's status was stable.

Event Description

It was reported that the stent was explanted.The target lesion was located in a severely calcified left vertebral artery.A 10.0-24mm carotid wallstent was implanted in the left subclavian artery.A 4.0mmx19mmx150cm express vascular sd stent was advanced but failed to deployed due to severe calcification.Then the express sd delivery system was withdrawn; however, the wallstent became explanted during removal of the stent delivery systm.The procedure was completed with a different device.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the delivery system was returned with the stent fully deployed.The deployed stent was also returned for analysis.A visual and tactile examination of the device identified no damage or any issues along the length of the catheter that could have contributed to the complaint incident.A visual and microscopic investigation identified no issues with the stent cup, stent holder or tip that could have contributed to the complaint incident.A visual and microscopic investigation identified that the distal end of the stent was damaged.This damage may have occurred when the stent became explanted by the express delivery system.No issues were noted with the stent 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 is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7732191
• MDR Text Key: 115417517
• Report Number: 2134265-2018-07295
• 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
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2021
• Device Model Number: H965SCH647120
• Device Catalogue Number: SCH-64712
• Device Lot Number: 21247989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention