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

Model Number H965SCH647120

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that stent recapturing difficulties were encountered.The 90% stenosed target lesion was located in a flat tortuous and mildly calcified carotid artery.A 10.0-24mm carotid wallstent¿ was advanced for treatment.However, when the physician tried to deploy the stent he was unsatisfied with the location of the stent when it was deployed for 50%.The physician tried to reconstrain and reposition the stent; however, he could only reconstrain the stent partially.The physician removed the whole system out of the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent recapturing difficulties were encountered.The 90% stenosed target lesion was located in a flat tortuous and mildly calcified carotid artery.A 10.0-24mm carotid wallstent¿ was advanced for treatment.However, when the physician tried to deploy the stent he was unsatisfied with the location of the stent when it was deployed for 50%.The physician tried to reconstrain and reposition the stent; however, he could only reconstrain the stent partially.The physician removed the whole system out of the patient's body and 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., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the device was returned with the stent fully mounted onto the delivery system.A visual and microscopic examination was performed on the returned device.The deployment handle was noted to be pushed forward.A visual and tactile examination identified severe catheter damage along the length of the device.One severe kink was noted 7mm distal to the distal edge of the proximal markerband.This kink extended from the outer sheath down into the inner shaft.Multiple smaller kinks and stretching damage was noted along the length of the catheter.Distal to the strain relief is was noted that the inner and outer shaft had completely detached from the strain relief.This detachment of the inner shaft and outer sheath prevented deployment and reconstrainment of the stent as the deployment handle could not be pushed forward or retracted.No issues were noted with the catheter that could have contributed to the complaint incident.The shaft damage identified is consistent with excessive force being applied to the delivery system.A visual and microscopic examination identified that approximately 8mm of stent was uncrimped and protruding from the inner shaft.This distal section of protruding stent was noted to be slightly damaged which may have occurred during attempts to reconstrain the device while at the target lesion.During analysis the investigator attempted to deploy the stent however due to the severe shaft damage identified in was not possible to deploy the stent using the deployment handle.To evaluate the stent and inner shaft the investigator attempted to manually deploy the stent.During this manual deployment the inner shaft broke at the location of the severe kink 7mm distal to the distal edge of the distal markerband.A visual and microscopic examination was performed on the deployed stent and inner shaft and no issues were noted that could have contributed to the complaint incident.A visual and microscopic examination was performed on the stent holder, tip and markerbands of the device.No damage or any issues were noted 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 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).

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7523924
• MDR Text Key: 108620064
• Report Number: 2134265-2018-04340
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2021
• Device Model Number: H965SCH647120
• Device Catalogue Number: SCH-64712
• Device Lot Number: 21518360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR