Model Number 26605 |
Device Problem
Material Separation (1562)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 11/27/2018 |
Event Type
Injury
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Additional information: describe event or problem, lot number, expiration date, unique identifier (udi) #, device manufacture date.Corrected initial reporter last name from (b)(6) to (b)(6).
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Event Description
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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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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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