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

Model Number 26605

Device Problems Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the shaft detached.The target lesion was located in the non-tortuous left internal carotid artery.A 9x40 carotid wallstent was successfully deployed.A 9 x 30 carotid wallstent was then selected for use.The stent was unable to be deployed.The device was unable to be completely pulled back.The shaft of the device detached 1 cm proximal from the proximal marker band.There was no strong resistance felt.Blood flowed over the right carotid through the circulum vilicity because the left side was occluded with the detached component.A new 9 x 30 carotid wallstent was implanted to affix and appose the detached component to the vessel wall.The patient condition after the procedure was fine and no adverse effects were reported.

Manufacturer Narrative

Initial reporter phone: (b)(6).Device analysis by mfr: the returned device consisted of carotid monorail.A visual and tactile examination of the catheter and delivery system identified a complete separation of the outer shaft located at the guidewire port.A complete separation of the inner shaft was also noted located proximal of the proximal markerband.The detached sections of the inner and outer shaft were not returned for analysis.This included the stent, both markerbands and the tip.This type of damage is consistent with excessive tensile force being applied to the device when attempting to remove it from the patient.A review of the angiographic images provided by the customer clearly indicates a restriction in the vessel where the first placed stent can be seen to narrow significantly.It is possible that when the physician attempted to deploy the second stent that the restriction in the vessel prevented them from doing so.The restriction would also have contributed to the resistance experienced as the user attempted to remove the device from the patient.The shaft separation is consistent with excessive tensile force being applied to the device when resistance is encountered during withdrawal.

Event Description

It was reported that the shaft detached.The target lesion was located in the non-tortuous left internal carotid artery.A 9x40 carotid wallstent was successfully deployed.A 9x30 carotid wallstent was then selected for use.The stent was unable to be deployed.The device was unable to be completely pulled back.The shaft of the device detached 1 cm proximal from the proximal marker band.There was no strong resistance felt.Blood flowed over the right carotid through the circulum vilicity because the left side was occluded with the detached component.A new 9x30 carotid wallstent was implanted to affix and appose the detached component to the vessel wall.The patient condition after the procedure was fine and no adverse effects were reported.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9036065
• MDR Text Key: 161054664
• Report Number: 2134265-2019-11187
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0024051117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 10/03/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention