MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number 26606

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified internal carotid artery.After a non-boston scientific (bsc) guidewire crossed the lesion and a non-bsc guide catheter was delivered to the common carotid artery, a 10.0-31 carotid wallstent was advanced to treat the lesion.Stent deployment in the lesion was tried, however, a slight resistance was felt but when about half was able to deployed somehow, more resistance was felt.When it was tried to deploy further, the t-connection part was slightly pulled but it could not be deployed.The stent was able to retract slightly, the system was removed and eventually, the device was retrieved.Subsequently, a 10-24 carotid wallstent was selected for use, and was delivered the same way.During deployment, the same resistance was still felt, and when about one-third was deployed, more resistance was felt but it was able to deploy as it was this time which completed the procedure.After the procedure, no damage was found on the delivery system.However, it was noticed that the proximal shaft of 10.0-31 carotid wallstent got stretched and the t-connection part could not be pulled out.About 15cm from the tip was about to separate.The 15cm part from the tip of the stent device was separated, but there was a report from the physician that when it was touched outside the patient, it got separated and remained inside the body.No further patient complications were reported.

Event Description

It was reported that shaft break occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified internal carotid artery.After a non-boston scientific (bsc) guidewire crossed the lesion and a non-bsc guide catheter was delivered to the common carotid artery, a 10.0-31 carotid wallstent was advanced to treat the lesion.Stent deployment in the lesion was tried, however, a slight resistance was felt but when about half was able to deployed somehow, more resistance was felt.When it was tried to deploy further, the t-connection part was slightly pulled but it could not be deployed.The stent was able to retract slightly, the system was removed and eventually, the device was retrieved.Subsequently, a 10-24 carotid wallstent was selected for use, and was delivered the same way.During deployment, the same resistance was still felt, and when about one-third was deployed, more resistance was felt but it was able to deploy as it was this time which completed the procedure.After the procedure, no damage was found on the delivery system.However, it was noticed that the proximal shaft of 10.0-31 carotid wallstent got stretched and the t-connection part could not be pulled out.About 15cm from the tip was about to separate.The 15cm part from the tip of the stent device was separated, but there was a report from the physician that when it was touched outside the patient, it got separated and remained inside the body.No further patient complications were reported.It was further reported that there was no fragment remained inside the patient.It was outside the body that the device was completely separated.The patient was in good condition after the procedure.

Manufacturer Narrative

B1: adverse event/product problem corrected to "product problem".

Manufacturer Narrative

Device evaluated by manufacturer: carotid wallstent monorail 10.0-31 was received for analysis.The device was received in two sections due to a complete detachment of the shaft.The device was received with the stent partially deployed on the delivery system.The exposed stent wires were noted to be damaged.The investigator was unable to deploy the stent due to a complete detachment of the shaft.A visual and tactile inspection identified two complete detachments of the outer shaft.The first detachment was located at the monorail port of the device.The second detachment was located approximately 27mm distal of the main t-valve.The shaft of the device was also found to have severe accordion damage beginning at the second shaft detachment and extending for approximately 20mm distally.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.

Event Description

It was reported that shaft break occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified internal carotid artery.After a non-boston scientific (bsc) guidewire crossed the lesion and a non-bsc guide catheter was delivered to the common carotid artery, a 10.0-31 carotid wallstent was advanced to treat the lesion.Stent deployment in the lesion was tried, however, a slight resistance was felt but when about half was able to deployed somehow, more resistance was felt.When it was tried to deploy further, the t-connection part was slightly pulled but it could not be deployed.The stent was able to retract slightly, the system was removed and eventually, the device was retrieved.Subsequently, a 10-24 carotid wallstent was selected for use, and was delivered the same way.During deployment, the same resistance was still felt, and when about one-third was deployed, more resistance was felt but it was able to deploy as it was this time which completed the procedure.After the procedure, no damage was found on the delivery system.However, it was noticed that the proximal shaft of 10.0-31 carotid wallstent got stretched and the t-connection part could not be pulled out.About 15cm from the tip was about to separate.The 15cm part from the tip of the stent device was separated, but there was a report from the physician that when it was touched outside the patient, it got separated and remained inside the body.No further patient complications were reported.It was further reported that there was no fragment remained inside the patient.It was outside the body that the device was completely separated.The patient was in good condition after the procedure.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16444333
• MDR Text Key: 310260533
• Report Number: 2124215-2023-08510
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0026802480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 92 YR
• Patient Sex: Male