Catalog Number AASLE06100 |
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 07/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: a voluntary recall has been initiated for the covera vascular covered stent which was product catalog/lot number specific.Reportedly the covera vascular covered stent has the potential to exhibit deployment issues (i.E., failure to deploy the covered stent) due to slide block bond failures in the device handle.Full or partial failure of the product to deploy is most likely to require percutaneous replacement with existing access.In rare cases, iatrogenic vascular injury may occur as the result of device withdrawal, manipulation, or abrupt/unexpected movements, particularly in the context of difficult or partial stent deployment or mispositioning.Adjunctive endovascular maneuvers may be indicated.There have been no cases where an open surgical procedure has been required.To date, there have been no reported patient injuries associated with deployment issues.As a result of the field action, this event is being reported as a malfunction reportable event.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent products are identified in d2 and g4.H10: 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.H10: d4 (expiry date: 10/2023).H11: section a through f: the information provide 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 : device pending return.
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Event Description
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It was reported that during a stent graft placement procedure in superficial femoral artery via femoral access, the thumb wheel was allegedly not working properly.It was further reported that the stent graft was not coming out of catheter.There was no reported patient injury.
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Event Description
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It was reported that during a stent graft placement procedure in superficial femoral artery via femoral access, the thumb wheel was allegedly not working properly.It was further reported that the stent graft was not coming out of catheter.There was no reported patient injury.
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Manufacturer Narrative
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H10: a voluntary recall has been initiated for the covera vascular covered stent which was product catalog/lot number specific.Reportedly the covera vascular covered stent has the potential to exhibit deployment issues (i.E., failure to deploy the covered stent) due to slide block bond failures in the device handle.Full or partial failure of the product to deploy is most likely to require percutaneous replacement with existing access.In rare cases, iatrogenic vascular injury may occur as the result of device withdrawal, manipulation, or abrupt/unexpected movements, particularly in the context of difficult or partial stent deployment or mispositioning.Adjunctive endovascular maneuvers may be indicated.There have been no cases where an open surgical procedure has been required.To date, there have been no reported patient injuries associated with deployment issues.As a result of the field action, this event is being reported as a malfunction reportable event.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent 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.Investigation summary: the delivery system was returned for evaluation and the covered stent was not deployed upon sample receipt.The slide block which is a force transmitting component 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 stent which leads to confirmed results.A force transmitting adhesive joint of the deployment mechanism was found loose which made a successful deployment impossible.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 root cause of this issue was considered to be related to a manufacturing step.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Regarding preparation the instruction for use states: "using standard endovascular access techniques and fluoroscopy, access the target vessel from a site that permits the straightest possible path to the target lesion and advance an 0.035 inch (0.89 mm) guidewire of appropriate length across the target lesion.H10: d4 (expiry date: 10/2023), g3, h6 (device).H11: h6 (method, result, conclusion).H11: section a through f: the information provide 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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Search Alerts/Recalls
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