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

Catalog Number LSM1350658

Device Problems Failure to Advance (2524); Difficult to Open or Remove Packaging Material (2922); Device Dislodged or Dislocated (2923)

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

Event Date 04/04/2023

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 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, 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 device was returned, the sleeve was not returned.The stent was clean but dislodged by 2mm from the distal marker band and over the proximal marker band.It was secure.It was slightly expanded at the distal end.A bend was evident along the length of the stent.No other damage was noted tot he stent or device.The result of the investigation is inconclusive for the difficulty to remove sleeve and failure to advance issues.The root cause for the difficulty to remove sleeve and failure to advance issues could not be determined based upon the available information received from the field communications, device evaluation and image review.Labeling review: the instruction 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.Storage: store in a cool, dry place.Keep away from sunlight.Use the device prior to the use by date specified on the package.Warnings: do not use if packaging/pouch is damaged.Use the device prior to the use by date specified on the package.Should excessive resistance be felt at any time during the insertion process, 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.Do not retract the balloon until the balloon is fully deflated under vacuum.Precautions: the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.Anatomical variances may complicate the procedure; 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.Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.L materials required for the lifestream¿ balloon expandable vascular covered stent procedure.Introducer sheath or guiding catheter with appropriate inner diameter.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 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.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 (expiry date: 04/2024).

Event Description

It was reported that during a stent graft placement procedure in the left iliac arterial occlusion via right femoral artery, the protector was allegedly unable to be removed.It was further reported that the stent graft was embedded in the center of the marker band on the balloon.Reportedly, the stent was inserted into the patient with the assistance of a pressure pump, but could not pass through the tortuous lesion.The stent was removed and the procedure was completed 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: 17304113
• MDR Text Key: 318827414
• Report Number: 9616666-2023-00124
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081499
• UDI-Public: (01)05391522081499
• 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
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350658
• Device Lot Number: CMFS0219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2021
• 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