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

Model Number 26605

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).

Event Description

It was reported that stent partial deployment and shaft break occurred.The occluded target lesion was located in the right internal carotid artery.An 8.0-36 carotid wallstent was advanced for treatment.However, during the procedure, the stent failed to expand.After removal, it was noted that the stent delivery system was broke into two pieces and the stent was not fully reconstrained.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital e1: initial reporter phone:(b)(6).Device evaluated by mfr: carotid wallstent monorail 8.0-36 was received for analysis.The following attributes were considered during analysis.A visual and tactile examination identified a complete separation of the outer sheath of the device located approximately 150mm proximal of the guidewire port.This type of damage is consistent with excessive force being applied to the device when attempting deployment.The device was returned with the stent in the correct position on the delivery system.The distal stent wires were noted to be damaged which an indication that deployment had been attempted.The investigator was unable to deploy the stent due to a separation of the outer sheath of the device.

Event Description

It was reported that stent partial deployment and shaft break occurred.The occluded target lesion was located in the right internal carotid artery.An 8.0-36 carotid wallstent was advanced for treatment.However, during the procedure, the stent failed to expand.After removal, it was noted that the stent delivery system was broke into two pieces and the stent was not fully reconstrained.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

• 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: 17745570
• MDR Text Key: 323402202
• Report Number: 2124215-2023-35128
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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: 0031416019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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: 67 YR
• Patient Weight: 66 KG