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

Model Number 26605

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that stent failed to be deployed.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified middle left internal carotid artery.An 8.0-36 carotid wallstent monorail was advanced into an 8f non-boston scientific (bsc) guide catheter and was engaged coaxially to cross the lesion.However, the stent was unable to be deployed once it was in position.Subsequently, the stent was repeatedly recaptured, but the problem was not resolved after many attempts.The stent was not fully reconstrained when removed from the patient's body.It was then suspected that the stent was irregular, but no damages were noted on the stent struts.The procedure was completed with another of same device.There were no patient complications reported, and the patient was stable post-procedure.However, returned device analysis revealed that the outer sheath was completely separated/detached.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).Device evaluated by mfr.: carotid wallstent monorail 8.0-36 was received for analysis.A visual and tactile examination identified a complete separation of the outer sheath of the device located approximately 70mm distal of the main t-valve.This type of damage is consistent with excessive force being applied to the device when attempting deployment.No other issues were noted with the delivery system.The device was returned with the stent partially deployed on the delivery system.The investigator was unable to deploy the stent due to a separation of the outer sheath of the device.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17749247
• MDR Text Key: 323737230
• Report Number: 2124215-2023-46715
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0028799994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG