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

Model Number H965SCH647080

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was received with the stent fully constrained on the delivery device.A significant quantity of dried blood was observed at the distal end of the device.The investigator was unable to deploy the stent and the proximal outer detached 20mm distal from the base of the shrink tubing as the investigator was attempting to deploy.The stent was deployed by cutting the distal outer and pulling the tip distally while gripping the stent outer.The stent was visually and microscopically examined.No issues were identified.The entire length of the stent was coated in dried blood.A visual inspection of the stent holder identified no issues.The imprinted stent impression was clearly evident on the stent holder.Dried blood was evident on both the stent holder and the inner.A visual and tactile inspection of the device identified no issues along the length 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 most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 22jun2017.The target lesion was located in the carotid artery.After placing a v-18 guide wire, predilation was performed and a 8.0-29 carotid wallstent was advanced to treat the lesion.However the stent failed to deploy.After several attempts of pulling back the outer sheath to deploy the stent, the device still failed.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed outer shaft separation at a portion that could enter the patient's body.

• 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: 6708765
• MDR Text Key: 79911028
• Report Number: 2134265-2017-06803
• 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
• Report Date: 06/22/2017

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: 11/19/2019
• Device Model Number: H965SCH647080
• Device Catalogue Number: SCH-64708
• Device Lot Number: 19282925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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