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

Catalog Number LSMU1350837

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/26/2023

Event Type  Injury  

Event Description

It was reported that during a stent graft placement procedure in the right common iliac artery via the right femoral access, the stent was allegedly found to have migrated into the aorta.It was further reported that the physician may have undersized the first stent, and then the second stent became attached to the first, and then both migrated upward.It was also reported that the stent balloon was inflated inside the stent in an attempt to pull it back down.Furthermore, attempts were made to snare the stent with no success.Reportedly, surgery was consulted, and a complete cutdown was done to access the iliacs and aorta to retrieve the stents that migrated.The current status of the patient is unknown.

Manufacturer Narrative

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 (expiration date: 12/2025) 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.H3 other text : device pending return.

Manufacturer Narrative

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: two stents were returned in packaging, the lifestream catheters were not returned for evaluation.Both stents exhibited expansion, one stent exhibited less expansion on one end 10mm section.Both stents were damaged and crushed.The damage was likely due to the reported surgical reintervention for the extraction of the stents.Fluoroscopy imagery or video files of the procedure were not provided.Therefore, the result of the investigation is confirmed for the reported stent migration issue.The definitive root cause for the reported stent migration issue could not be determined based upon the available information received from the field communications and sample evaluation.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: indication for use: the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.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.Warnings: ¿ 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.¿ stenting across a vessel side branch may impede blood flow and hinder or prevent future procedures.¿ stenting into a bifurcation may compromise future diagnostic or therapeutic procedures.- 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.Storage: store in a cool, dry place.Keep away from sunlight.Use the device prior to the use by date specified on the package.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.¿ crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.¿ this device has not been tested for use in overlapped conditions with stents or covered stents from other manufacturers.¿ do not use if the delivery system cannot be properly flushed.Directions for use: site access and preparation: 2.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Endovascular system preparation: 4.Carefully remove the selected device from the package.5.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.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.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.Placement of two overlapped covered stents: 18.In the event that two covered stents must be placed overlapped, place the distal covered stent first.Ensure approximately 10 mm overlap zone.H10: d4 (expiration date: 12/2025), g3, h6 (device).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.

Event Description

It was reported that during a stent graft placement procedure in the right common iliac artery via the right femoral access, the stent was allegedly found to have migrated into the aorta.It was further reported that the physician may have undersized the first stent, and then the second stent became attached to the first, and then both migrated upward.It was also reported that the stent balloon was inflated inside the stent in an attempt to pull it back down.Furthermore, attempts were made to snare the stent with no success.Reportedly, surgery was consulted, and a complete cutdown was done to access the iliacs and aorta to retrieve the stents that migrated.The current status of the patient is unknown.

• 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: 17378043
• MDR Text Key: 319597742
• Report Number: 9616666-2023-00131
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081222
• UDI-Public: (01)05391522081222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSMU1350837
• Device Lot Number: CMHN0191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 78 KG