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

Catalog Number	LSMU0800726
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a stent graft placement procedure, the protector and the stent allegedly fell off together from the mounting balloon while the protective cover was being removed.There was no patient contact.
Additional Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream product that are cleared in the us.The pro code and 510k number for the lifestream product is identified in d2 and g4.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records was performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that prior to a stent graft placement procedure, the protector and the stent allegedly fell off together from the mounting balloon while the protective cover was being removed.There was no patient contact.
Event or Problem Description
It was reported that prior to a stent graft placement procedure, the protector and the stent allegedly fell off together from the mounting balloon while the protective cover was being removed.There was no patient contact.
Additional 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: the lifestream device was returned for evaluation.The stent was returned separate to the catheter lodged within the sleeve towards one end.There was no evidence of stent expansion.No damage was noted.The balloon exhibited no evidence of inflation.The pleats, folds and crimp indentations were intact.No damage was noted.Therefore, the result of the investigation is confirmed for the reported stent dislodgment issue.The root cause for the reported stent dislodgement issue could not be determined based upon the available information.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.¿ 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.¿ 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: 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: 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.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.

• Brand Name: LIFESTREAM
• Common Device Name: 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: 20437099
• Report Number: 9616666-2024-00259
• Device Sequence Number: 20831942
• Product Code: PRL
• UDI-Device Identifier: 05391522081093
• UDI-Public: (01)05391522081093(11)230630(17)260531(10)CMHT0437
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: LSMU0800726
• Device Lot Number: CMHT0437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 11/20/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/14/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown