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

Model Number H7493915010310

Device Problem Capturing Problem (2891)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

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.Bsc id: (b)(4).Tw: (b)(4).

Event Description

It was reported that stent reconstrainment difficulty occurred.A 10.0-31 carotid wallstent¿ was advanced to treat a lesion.Following deployment of about 20%, the physician decided to change the position.However, it was noted that resistance was met while resheathing and the device was retrieved while slightly deployed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: the delivery system was returned with the stent deployed.The deployed stent was not returned for analysis.A visual and tactile examination identified a severe shaft kinking and stretching damage along the length of the device.The majority of the damage was noted approximately 1260mm distal to the strain relief.Both the inner shaft and outer sheath were severely kinked and stretched.The outer sheath was also noted to be fully retracted and could not be repositioned over the inner shaft during analysis due to the severe shaft damage.The damage identified is consistent with excessive force being applied to the delivery system.No issues were noted with the catheter that could have contributed to the damage identified.A visual and microscopic examination was performed on the stent holder, stent cups and markerbands of the device.No damage or any issues were noted that could have contributed to the complaint incident.A visual and microscopic examination identified that the tip of the device was damaged.A section of the tip approximately 2mm in length was noted to be completely detached from the device.This detached section of tip was not returned for analysis.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 stent reconstrainment difficulty occurred.A 10.0-31 carotid wallstent was advanced to treat a lesion.Following deployment of about 20%, the physician decided to change the position.However, it was noted that resistance was met while resheathing and the device was retrieved while slightly deployed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7723643
• MDR Text Key: 115200985
• Report Number: 2134265-2018-06798
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• 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: 08/28/2018
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1