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

Model Number H7493915010310

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis.The device was received with the stent partially deployed on the delivery system.The investigator was unable to deploy the stent using the handle due to a complete break of the outer shaft.The stent was deployed by pulling the tip distally while gripping the stent outer.The stent was visually and microscopically examined and no issues were identified.A visual and microscopic investigation identified no issues with the stent cup or stent holder that could have contributed to the complaint incident.The imprinted stent impression was clearly visible on the stent holder.A visual and tactile inspection identified a complete break of the shaft of the device located approximately 80mm distal of the main valve of the device.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.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 operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on analysis completed on 05 july 2018.It was reported that difficulty deployment occurred.The target lesion was located in the tortuous internal carotid artery branch of common carotid artery.After a filter wire crossed the lesion with the support of 9f non-bsc guide catheter, pre-dilation was performed.A 10.0-31mm carotid wallstent¿ stent was advanced to treat the lesion.However, difficulty deployment was encountered due to resistance.The procedure was completed with another of the same device.No patient complications nor injuries were reported.However, returned device analysis revealed shaft detached/separated.

• 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: 7723373
• MDR Text Key: 115401653
• Report Number: 2134265-2018-06618
• 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
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: H7493915010310
• Device Catalogue Number: 39150-1031
• Device Lot Number: 0022103557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• 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