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Catalog Number FEM14040 |
Device Problems
Positioning Failure (1158); Material Perforation (2205); Misfire (2532)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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: 05/2025).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.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 the subclavian vein via the right arm fistula, the stent allegedly failed to deploy.It was further reported that when the stent was pulled out of the patient, it appeared that a strut was sticking out.The procedure was completed using another device.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 the subclavian vein via the right arm fistula, the stent allegedly failed to deploy.It was further reported that when the stent was pulled out of the patient, it appeared that a strut was sticking out.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 stent delivery system was returned for evaluation and one of the stent struts was found perforating the sheath while the stent was partially deployed.It is considered the perforation of the sheath led to the impossibility to completely deploy the stent graft which leads to confirmed results.It was reported that a 10f introducer / 0.035" guidewire were used for access, the vessel was neither tortuous nor calcified, the lesion was pre-dilated and the device was flushed prior to use.Based on the provided information and the evaluation of the returned sample, the investigation is closed with confirmed results for sheath perforation and misfire of the stent graft is considered a cascading event.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use (ifu) sufficiently address the potential risks.The instructions for use state: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' regarding preparation of the device the instructions for use state that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment".Regarding the anatomy of the placement site the instructions for use states: "prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy".Regarding accessories the instructions for use states: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended".The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.H10: d4 (expiry date: 05/2025), g3, h6 (device).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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Search Alerts/Recalls
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