Catalog Number AASLE06080 |
Device Problems
Loss of or Failure to Bond (1068); Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a stent graft placement procedure, the stent allegedly unable to deploy.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent system products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system products are identified in d2 and g4.H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was returned for evaluation and the slide block which is a force transmitting component inside the grip was no longer connected to the proximal sheath.It is considered the disconnection of the slide block led to the reported impossibility to deploy the covered stent which leads to confirmed results.Based on evaluation of the sample the inability of an adhesive joint (slide block/tether/diving sheath) to withstand tension force during deployment is confirmed.A definite root cause for the reported event could not be established.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to deployment forces.Regarding correct deployment the instructions for use states: "maintain a stationary hold on the white stability sheath during covered stent deployment.Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath relaxed and avoid tension." based on the instructions for use material required for a procedure using the covera plus vascular covered stent are 0.035-inch guidewire of appropriate length, introducer sheath with appropriate inner diameter.Regarding preparation the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." h10: d4 (expiration date: 03/2024).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Manufacturer Narrative
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H10: additional information was received, and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent system products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system products are identified in d2 and g4.H10: d4 (expiration date: 03/2024), g3.H11: b3.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
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Event Description
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It was reported that during a stent graft placement procedure, the stent allegedly unable to deploy.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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