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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID
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BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Device Problems Break (1069); Fracture (1260); Material Deformation (2976)
Patient Problems Embolism (1829); Occlusion (1984); Paralysis (1997); Stenosis (2263); Device Embedded In Tissue or Plaque (3165)
Event Date 09/11/2019
Event Type  Injury  
Event Description
It was reported that two strut ends of the stent detached, moved to the brain, and created two occlusions.The patient had neurological symptoms and required additional intervention.A carotid wallstent was implanted on (b)(6) 2019 with a good result and a fully opened stent.On approximately (b)(6) 2019 , the patient underwent a patent foramen ovale (pfo) closure procedure.On (b)(6) 2019, the patient had neurological symptoms with hemiparesis on the right side.A ct scan was performed on (b)(6) 2019.It was observed that the stent was deformed, and two strut ends of the carotid wallstent detached and moved to the brain.Both fragments were approximately 8mm long.The fragments went into the brain vessels and created two occlusions.The patient was neurologically symptomatic with hemiparesis for one day but recovered.A doublelayer stent was placed over the carotid wallstent and the patient was under antithrombotic therapy.
 
Event Description
It was reported that two strut ends of the stent detached, moved to the brain, and created two occlusions.The patient had neurological symptoms and required additional intervention.A carotid wallstent was implanted on (b)(6) 2019 with a good result and a fully opened stent.On approximately (b)(6) 2019 , the patient underwent a patent foramen ovale (pfo) closure procedure.On (b)(6) 2019, the patient had neurological symptoms with hemiparesis on the right side.A ct scan was performed on (b)(6) 2019.It was observed that the stent was deformed, and two strut ends of the carotid wallstent detached and moved to the brain.Both fragments were approximately 8mm long.The fragments went into the brain vessels and created two occlusions.The patient was neurologically symptomatic with hemiparesis for one day but recovered.A doublelayer stent was placed over the carotid wallstent and the patient was under antithrombotic therapy.
 
Manufacturer Narrative
Device eval by manufacturer: the complaint device was not received for analysis.The device remains implanted and in service.Full angiography from the index procedure was requested from the customer, however it was not received.The customer did provide a selected number of photographic images of the ct (computerized tomography) that was carried out.The review of the provided still angiographic images cannot conclusively identify the alleged fractures in the deployed device.At the locations, where it appears to be a fracture in the braided rods defined by a potentially missing radiopaque continuity, faint radiopaque lines were identified.Intersection points with enhanced radiopacity, characteristic of an overlap of rods, were also identified.It was concluded that the intensity of the radiopacity, in the provided images, change depending of where the braided rods are located (front or back).It also changes at the overlap location depending of the selected projection and shape of the braided rod at that moment where the still image was taken.The overlap can be observed at the points where the braided rods intersect and/or through the full-length of the selected stent segment where the rods in the front plane overlap with the rods in the back plane depending of the projection recorded in the image.The review of the provided still images is consistent with the allegation in identifying two filaments segments located in the brain, however it could not conclude that the source of those filaments was the carotid wallstent successfully implanted more than two months prior a procedure, where an unknown closure device was used, and where 11 days after this pfo procedure, the neurological symptoms were recorded diagnosing the filaments in the brain as the primary cause.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9199124
MDR Text Key162553890
Report Number2134265-2019-12401
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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