Model Number N/A |
Device Problem
Positioning Problem (3009)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 12/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
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Event Description
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The user facility reported that the involved destination was used during the procedure.During surgery on the iliac artery, the patient presents a major dissection of this artery which requires the placement of a covered stent.The surgeon has great difficulty fitting this stent into the introducer.Three other stents are necessary for the patient's management and for these 3 stents, the surgeon experiences the same difficulties when fitting them in the introducer.An x-ray check was performed after insertion and it showed that the first stent was "loose" and no abnormalities on the "other inserted stents".In view of the seriousness of the situation; arterial dissection in an elderly patient the speed of the stent placement was essential.The delay in management due to the faulty introducer resulted in a very significant drop in blood pressure.Fortunately, the patient will have no long-term clinical consequences.
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Manufacturer Narrative
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This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device has not been returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for mobility issues since the sample was not returned for evaluation.Based on the information given, the exact root cause of the event cannot be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
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Manufacturer Narrative
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This report is being submitted as follow up no.2 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.One used 6 fr 45 cm destination sheath and dilator was received for product evaluation.The dilator was mated to the sheath when received.The sheath was subjected to visual analysis and stretched at different segments.The outer diameter of the sheath was 0.1088 in which is within manufacturer specifications.The inner diameter of the sheath is 0.086" which was also within manufacturer specifications.There was difficulty experienced to advance the dilator through the sheath.When further examined, the sheath was stretched at different segments and slight bumps were noted at 3.7 and 7.5 cm from the hub.Furthermore, the tip of the sheath also experienced tears.There were no damages noted on the dilator.The complaint can be confirmed for mobility issues.Based on the information given, the exact root cause of the event cannot be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
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Manufacturer Narrative
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This report is being submitted as follow up no.3 to provide additional information in sections b5 and d10.
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Event Description
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Additional information was received on 26apr2021.7x37mm stents manufactured by bentley were used.The arteries were quite tortuous with significant calcification.
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Search Alerts/Recalls
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