Catalog Number AASLE06060 |
Device Problems
Loss of or Failure to Bond (1068); Break (1069); Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us but is similar to the covera plus vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2023).
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Event Description
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It was reported that during a stent placement procedure in the renal artery, the stent was allegedly broken.It was further reported that the device was allegedly failed to deploy.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 that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent 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.Investigation summary: the sample was returned for evaluation.The delivery system was found with the covered stent in system and in place.The slide block of this device was found no longer connected to proximal sheath.Based on the condition of the sample it is concluded that the slide block getting disconnected from the proximal sheath, led to the reported impossibility to deploy the stent.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.The stent should be placed in the renal artery during treatment of an abdominal aortic aneurysm (aaa), which represent an off label use and a tortuous tracking path by nature.The definitive root cause could not be determined based upon available information.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 failure to deploy and high 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." regarding preparation and accessories, 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." and "0.035 inch (0.89 mm) guidewire of appropriate length (¿) introducer sheath with appropriate inner diameter and length." the intended placement in the celiac artery represents an off label use of the device.Based on the instructions for use supplied with this product the covera plus vascular covered stent is indicated for the treatment of stenoses in the upper extremity venous outflow of patients dialyzing with an arterio-venous (av) access graft or fistula and for the treatment of atherosclerotic lesions in iliac and femoral arteries with a reference vessel diameter of 4.5 mm to 9 mm.H10: (expiry date: 09/2023).H11: section a through f - the information provided by bd represents all of 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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Event Description
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It was reported that during a stent placement procedure in the renal artery, the stent was allegedly broken.It was further reported that the device was allegedly failed to deploy.There was no reported patient injury.
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Search Alerts/Recalls
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