MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM; BALLOON EXPANDABLE VASCULAR COVERED STENT

Catalog Number LSM1350837

Device Problems Separation Failure (2547); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure in the subclavian artery via the brachial artery puncture, when the balloon was withdrawn after dilation, the stent was not found in the lesion position and was allegedly found to be left in the sheath.It was further reported that the stent was not released.The procedure was completed by using another device.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 lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream 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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2025) 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.

Event Description

It was reported that during a stent graft placement procedure in the subclavian artery via the brachial artery puncture, when the balloon was withdrawn after dilation, the stent was not found in the lesion position and was allegedly found to be left in the sheath.It was further reported that the stent was not released.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified in d2 and g4.Manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, a device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.The balloon exhibited previous inflation.The stent did not show evidence of expansion and was flattened and squashed throughout.The damage likely occurred during its removal from the sheath (not returned) by the healthcare personnel.A 8-second video-fluoroscopy of an endovascular procedure was also provided for review.The findings showed the deployment video and depicted a stent graft that appeared to be in the abdominal aorta.The lumbar spine and contrast-enhanced left renal calyx were seen nearby.A balloon introduced through a sheath from above was being inflated.A stent was not seen.The video did not depict the case presented in this complaint; i.E.Attempted subclavian artery covered stent placement via a brachial access.The video provided appeared to depict angioplasty of an aortic branch vessel through a previously-deployed stent-graph in the abdominal aorta.Therefore, the result of the investigation is confirmed for the reported stent dislodgment issue.The root cause for the reported stent dislodgment issue could not be determined based upon the available information received from the field communications, device evaluation and video review.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: the lifestream¿ balloon expandable vascular covered stent is supplied sterile (by ethylene oxide) and is intended for single use only.Do not resterilize.After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications.Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.Do not use the device if sterile packaging/pouch has been damaged or unintentionally opened prior to use.Use the device prior to the use by date specified on the package.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.Use only diluted contrast medium for balloon inflation.Do not use air or any gaseous medium to inflate the balloon as this may cause uneven expansion and difficulty in deployment of the covered stent.For the contrast/saline solution, a ratio of 50/50 is recommended.The covered stent cannot be repositioned after it is deployed.Do not retract the balloon until the balloon is fully deflated under vacuum.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.Prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.Do not use if the delivery system cannot be properly flushed.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.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.6.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.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.D4 (expiration date: 09/2025).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.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products 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, a device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.The balloon exhibited previous inflation.The stent did not show evidence of expansion and was flattened and squashed throughout.The damage likely occurred during its removal from the sheath (not returned) by the healthcare personnel.Therefore, the result of the investigation is confirmed for the reported stent dislodgment issue.The root cause for the reported stent dislodgment issue could not be determined based upon the available information received from the field communications and device evaluation.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: ¿ the lifestream¿ balloon expandable vascular covered stent is supplied sterile (by ethylene oxide) and is intended for single use only.Do not resterilize.After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications.Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.¿ do not use the device if sterile packaging/pouch has been damaged or unintentionally opened prior to use.¿ use the device prior to the use by date specified on the package.¿ 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.¿ use only diluted contrast medium for balloon inflation.Do not use air or any gaseous medium to inflate the balloon as this may cause uneven expansion and difficulty in deployment of the covered stent.For the contrast/saline solution, a ratio of 50/50 is recommended.¿ the covered stent cannot be repositioned after it is deployed.¿ do not retract the balloon until the balloon is fully deflated under vacuum.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.¿ prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.¿ do not use if the delivery system cannot be properly flushed.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.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.6.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.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.H10: d4 (expiration date: 09/2025), g3, h6 (method) h11: h6 (device, 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.

Event Description

It was reported that during a stent graft placement procedure in the subclavian artery via the brachial artery puncture, when the balloon was withdrawn after dilation, the stent was not found in the lesion position and was allegedly found to be left in the sheath.It was further reported that the stent was not released.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18235842
• MDR Text Key: 329314289
• Report Number: 9616666-2023-00234
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350837
• Device Lot Number: CMGX0427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1