Catalog Number VIEL08100 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/21/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestar vascular stent that are cleared in the us.The pro code and 510 k number for the lifestar vascular stent 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 device has not been returned to the manufacturer for evaluation.However, a video and images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2024).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.H3 other text : device not returned.
|
|
Event Description
|
It was reported that during a stent placement procedure in the right iliac artery via right common femoral artery approach, when the stent was inserted over the guide wire and released, it was measured to be over one hundred and twenty millimeters in length, extending beyond the planned position.It was further reported that the planned placement was completely covered, but the healthy tissue was also covered to the proximal end of the stent.The procedure was completed by placing an additional stent inside the elongated stent and then ballooned.There was no reported patient injury.
|
|
Event Description
|
It was reported that during a stent placement procedure in the right iliac artery via right common femoral artery approach, when the stent was inserted over the guide wire and released, it was measured to be over one hundred and twenty millimeters in length, extending beyond the planned position.It was further reported that the planned placement was completely covered, but the healthy tissue was also covered to the proximal end of the stent.The procedure was completed by placing an additional stent inside the elongated stent and then ballooned.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestar vascular stent that are cleared in the us.The pro code and 510 k number for the lifestar vascular 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.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 physical sample was not available for evaluation.Provided images/ movie demonstrate the deployed stent inside patient including a digital length measurement of 132mm which indicates stent elongation of the 100mm stent.The course of the stent deployment from beginning to end was not demonstrated on the provided images/ movie.A detailed strut analysis for elongation was not possible due to poor resolution.The vessel was not tortuous/ calcified, and the user pined the grip in place, and removed slack before deployment; the target site was seen between the markers before deployment, and the system was kept straight; the user did not experience difficulty during deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for stent elongation.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describe holding and handling of the system during deployment; in particular the instruction for use state: 'prior to stent deployment, remove all slack from the catheter delivery system to avoid stent misplacement.', and 'deploy the stent using the ¿pin & pull-back¿ technique by slowly pulling back the distal t-luer adapter (f) towards the hand that is pinned in place', and 'the radiopaque markers on the stent must not move during stent deployment.' in regard to access and accessories the instruction for use state: 'the lifestar vascular stent system is only compatible with a 0.035-inch (0.89 mm) guidewire.', and 'the 6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.', and 'via the femoral route, insert a 0.035-inch (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion.' in regard to pta the instruction for use state: 'pre-dilatation of the stricture is recommended.' in regard to stent size selection the instructions for use state: 'allow approximately 5 ¿ 10 mm of the stent to extend beyond each end of the stricture.', and 'the lifestar vascular stent experiences length changes less than 10% during deployment if appropriate oversizing is used.H10: d4 (expiration date: 10/2024), g3.H11: h6 (method, result, conclusion).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 : device not returned.
|
|
Search Alerts/Recalls
|
|