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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream that are cleared in the us.The pro code and 510k number for the lifestream 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.However, photos and images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 09/2025).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.
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It was reported that during a stent placement procedure, the device hub strain allegedly detached.It was further reported that the part was implanted initially at the left subclavian artery and then allegedly migrated to an arm.Reportedly, the patient allegedly experienced ischemia.The patient had to undergo additional intervention to remove the part and was successful and the ischemia has healed.The current status of the patient is unknown.
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream that are cleared in the us.The pro code and 510 k number for the lifestream are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the lifestream catheter was not returned for evaluation.The catheter hub strain relief was returned.No damage was noted to the strain relief.User handling and procedure techniques likely contributed to the reported strain relief detachment and migration issues.Four x-ray images and one photo were provided for review.The images indicated a procedure placing a stent in the subclavian artery after thoracic stent graft repair.This indicates the device use was off label.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.It is likely that the off label use of the lifestream device contributed to the user being unsure if the device had reached the target site.This led to the reported force used to push the delivery system into the sheath and reported potential detachment of the strain relief inside the sheath.The strain relief component is designed to not pass into or through the sheath valve or hub.The definitive root cause for the device strain relief detachment and migration issue could not be determined based upon the available information received from the field communications, component returned and images reviewed.Labeling review: the instructions for use for this lifestream device was reviewed and the following sections are applicable.B) indication for use: the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.C) contraindications: the lifestream¿ balloon expandable vascular covered stent is contraindicated for use in: ¿ patients with uncorrected bleeding disorders.¿ patients who cannot receive recommended antiplatelet and/or anticoagulation therapy.¿ patients who are judged to have lesions that prevent complete expansion of the implant based on the lesion morphology, the diagnostic angiography and/or lesion response during pre-dilation.¿ lesions in which the lumen diameter post balloon angioplasty is insufficient for the passage of the endovascular system.¿ lesion locations subject to external compression.D) warnings: ¿ should excessive resistance be felt at any time during the procedure, do not force passage.¿ attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent.Maintain guidewire placement across the lesion and withdraw the endovascular system only until the proximal end of the covered stent is aligned with the tip of the sheath/guiding catheter.Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter.Remove the sheath/guiding catheter and endovascular system as a single unit.Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement.¿ the covered stent cannot be repositioned after it is deployed.E) precautions: ¿ the device should only be used by physicians who are trained in endovascular procedures and are familiar with the required devices and materials, complications, side effects and hazards of peripheral vascular interventions.¿ anatomical variances and pre-existing conditions may complicate the procedure; always check the patient¿s medical history before starting the procedure and use caution when advancing the endovascular system through tortuous or difficult anatomy.¿ prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.¿ keep dry.Keep away from sunlight.J) storage: store in a cool, dry place.Keep away from sunlight.Use the device prior to the use by date specified on the package.M) directions for use: site access and preparation: 1.Using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.2.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Covered stent size selection: 3.Select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.Endovascular system preparation: 4.Carefully inspect the pouch to ensure that the sterile barrier has not been compromised.Carefully remove the selected device from the package.5.Examine the stent system to ensure it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.Air evacuation: 7.A 20 cc or smaller luer-lock syringe with a minimum of 5 cc¿s sterile saline mixture is recommended for use for aspirating this device.8.With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.9.Induce a negative pressure to remove any air from the balloon and inflation lumen.Repeat until all air is expelled.10.Carefully release to neutral.Allow the inflation lumen to fill with the diluted contrast medium and maintain a neutral pressure.Important: do not apply positive pressure to the balloon.11.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.12.Verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter.Introduction of the endovascular system and placement of the covered stent: 13.Advance the endovascular system over the guidewire into the introducer sheath.14.Further advance the endovascular system to the target treatment site within the introducer sheath and position the covered stent across the lesion.Verify that the covered stent is still centered within the balloon marker bands.Slowly retract the introducer sheath/guiding catheter while maintaining the position of the covered stent.Ensure the introducer sheath is retracted far enough to not compromise the balloon expansion and covered stent release.15.Slowly inflate the endovascular system balloon to nominal pressure, expanding the covered stent.Confirm complete expansion via fluoroscopic visualization.A 15 ¿ 30 second inflation time is recommended.Important: do not exceed the rated burst pressure of the delivery system.16.After covered stent deployment, apply negative pressure to the balloon until it is fully deflated.Withdraw the delivery system while maintaining negative pressure with the guidewire remaining across the lesion.17.Confirm optimal covered stent wall apposition using standard angiographic techniques.If the covered stent has not achieved full wall apposition, a post dilation with an appropriately sized balloon should be performed.5-8 mm devices may be post-dilated with balloons up to 10 mm in diameter.9-12 mm devices may be post-dilated with balloons up to 12 mm in diameter.H10: d4 (expiration date: 09/2025), 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 : see h10.
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It was reported that during a stent placement procedure, the device hub strain allegedly detached.It was further reported that the part was implanted initially at the left subclavian artery and then allegedly migrated to an arm.Reportedly, the patient allegedly experienced ischemia.The patient had to undergo additional intervention to remove the part and was successful and the ischemia has healed.The current status of the patient is unknown.
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