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

Catalog Number LSMU1350637

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported that prior to a stent graft placement procedure, the stent was allegedly dislodged.There was no patient contact.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4: (expiry date: 04/2026).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: manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number and the lot met all release criteria.Therefore, a device history record review is not required.Investigation summary: the lifestream device was not returned for evaluation.However one image was provided for review.The image showed a lifestream carton device with the lot number was visible.This complies with the lot number logged on the gcs.The lifestream device was not shown.The result of the investigation is inconclusive 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 image review.Labeling review: the instruction 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.¿ the covered stent cannot be repositioned after it is deployed.¿ do not expose the covered stent to temperatures higher than 500 °f (260 °c).Eptfe decomposes at elevated temperatures, producing highly toxic decomposition products.¿ use of a laser on or around the surface of the covered stent may result in damage to the covered stent and could create toxic fumes, which may harm the patient or operator.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.¿ crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.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.H10: d4 (expiry date: (b)(6) 2026), g3, h6 (method) 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 prior to a stent graft placement procedure, the stent was allegedly dislodged.There was no patient contact.

• 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: 18791112
• MDR Text Key: 336523679
• Report Number: 9616666-2024-00050
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081062
• UDI-Public: (01)05391522081062
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSMU1350637
• Device Lot Number: CMHS0488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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