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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
Model Number 26606
Device Problem Fracture (1260)
Patient Problems Stroke/CVA (1770); Foreign Body In Patient (2687)
Event Date 02/09/2022
Event Type  Injury  
Manufacturer Narrative
(b)(6).Implanted date: 2018.
 
Event Description
It was reported that a stent fracture and mild cerebral infarction occurred.The target lesion was located in the internal carotid and common carotid arteries.A 10.0-31 carotid wallstent monorail stent was implanted in 2018.During follow up, it was noticed that the distal part of the stent was fractured inside the patient.A mild cerebral infarction was noted, and a computerized tomography scan showed something white, as if something like a piece of metal was flying around.Additional information was requested and has not been received.No further patient complications were reported.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6) general hospital.D6a: implanted date: 2018.Device eval.By manufacturer: the carotid device was not returned for analysis.However images of the stent were provided by the customer and were reviewed.From the images provided by the customer, it could not be positively confirmed that the stent was fractured; however it could be confirmed that the distal stent wires had been damaged.H3 other text : media.
 
Event Description
It was reported that stent fracture and mild cerebral infarction occurred.The target lesion was located in the internal carotid and common carotid arteries.A 10.0-31 carotid wallstent monorail stent was implanted in 2018.However, during follow up, it was noticed that the distal part of the stent was fractured inside the patient.A mild cerebral infarction was noted and the computerized tomography scan showed something white as if something like a piece of metal was flying around.No further patient complications were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13655568
MDR Text Key286494711
Report Number2134265-2022-01813
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/08/2022
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 Model Number26606
Device Catalogue Number26606
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/09/2022
Initial Date FDA Received03/02/2022
Supplement Dates Manufacturer Received03/14/2022
Supplement Dates FDA Received04/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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