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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 26605
Device Problem Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/27/2018
Event Type  Injury  
Event Description
It was reported that metal fragments were in the patient's brain.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left carotis interna.The carotis was first stented with an unspecified stent.Two wallstent endoprosthesis with unistep plus delivery systems were used in a percutaneous transluminal angioplasty.The procedure was successful and nothing abnormal.Subsequently, a non-bsc stent retriever was used for media thrombectomy.Intervention was successfully finished.24 hours later, a computerized tomography (ct) scan was done for control.Metal fragments were seen in the left side brain.It is not clear from which device the fragments are from: stent retriever or carotid stent(s).No attempts were made to retrieve the fragments as it was not possible and had no influence of the patient's health.The physician does not plan to remove the fragment.No further patient complications were reported.
 
Event Description
It was reported that metal fragments were in the patient's brain.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left carotis interna.The carotis was first stented with an unspecified stent.Two wallstent endoprosthesis with unistep plus delivery systems were used in a percutaneous transluminal angioplasty.The procedure was successful and nothing abnormal.Subsequently, a non-bsc stent retriever was used for media thrombectomy.Intervention was successfully finished.24 hours later, a computerized tomography (ct) scan was done for control.Metal fragments were seen in the left side brain.It is not clear from which device the fragments are from: stent retriever or carotid stent(s).No attempts were made to retrieve the fragments as it was not possible and had no influence of the patient's health.The physician does not plan to remove the fragment.No further patient complications were reported.
 
Manufacturer Narrative
Brand name corrected from wallstent endoprosthesis with unistep plus delivery system to carotid wallstent.Common device name corrected from catheter, biliary, diagnostic to stent, carotid.Pro code (product code) corrected from fge to nim.Model number and catalog number updated to 26605.Mfr site facility name corrected from boston scientific limited to boston scientific ireland limited.
 
Manufacturer Narrative
Additional information: describe event or problem, lot number, expiration date, unique identifier (udi) #, device manufacture date.
 
Event Description
It was reported that metal fragments were in the patient's brain.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left carotis interna.The carotis was first stented with an unspecified stent.Two wallstent endoprosthesis with unistep plus delivery systems were used in a percutaneous transluminal angioplasty.The procedure was successful and nothing abnormal.Subsequently, a non-bsc stent retriever was used for media thrombectomy.Intervention was successfully finished.24 hours later, a computerized tomography (ct) scan was done for control.Metal fragments were seen in the left side brain.It is not clear from which device the fragments are from: stent retriever or carotid stent(s).No attempts were made to retrieve the fragments as it was not possible and had no influence of the patient's health.The physician does not plan to remove the fragment.No further patient complications were reported.It was further reported that three fragments were seen measuring 6x1.5mm, 3x1.5mm, 3x1.5mm.Patient was recommended for ct control but has not been terminated.
 
Manufacturer Narrative
Angiographical media review: the available angiographic images recorded the assessment of the vessels and the two implanted carotid wallstents.No angiographs from the positioning or deployment stages were made available.After the deployment of the stents a good patent vessel is observed as a result.Above the stent, in the cranial direction, there is severe tortuosity where haziness can be identified, also a unfilled focalized segment was observed.The media review can confirm that there are not any apparent structural damages observed in the deployed stents that could have induced metallic fragmentation.
 
Event Description
It was reported that metal fragments were in the patient's brain.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left carotis interna.The carotis was first stented with an unspecified stent.Two wallstent endoprosthesis with unistep plus delivery systems were used in a percutaneous transluminal angioplasty.The procedure was successful and nothing abnormal.Subsequently, a non-bsc stent retriever was used for media thrombectomy.Intervention was successfully finished.24 hours later, a computerized tomography (ct) scan was done for control.Metal fragments were seen in the left side brain.It is not clear from which device the fragments are from: stent retriever or carotid stent(s).No attempts were made to retrieve the fragments as it was not possible and had no influence of the patient's health.The physician does not plan to remove the fragment.No further patient complications were reported.It was further reported that three fragments were seen measuring 6x1.5mm, 3x1.5mm, 3x1.5mm.Patient was recommended for ct control but has not been terminated.
 
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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 Key8143333
MDR Text Key129654335
Report Number2134265-2018-63659
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
K992510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 08/19/2019
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 Date04/05/2022
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0022752874
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received12/07/2018
Supplement Dates Manufacturer Received02/21/2019
04/02/2019
08/12/2019
Supplement Dates FDA Received02/28/2019
04/17/2019
08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
STENT RETRIEVER: STRYKER TREVO; STENT RETRIEVER: STRYKER TREVO; STENT RETRIEVER: STRYKER TREVO; STENT RETRIEVER: STRYKER TREVO; STENT RETRIEVER: STRYKER TREVO
Patient Outcome(s) Other;
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