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

Model 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	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 07/2024).
Event or Problem Description
It was reported that prior to a stent placement procedure in the external iliac artery via an ipsilateral retrograde approach, the stent allegedly dislodged.There was no patient contact.
Event or Problem Description
It was reported that prior to a stent placement procedure in the external iliac artery via an ipsilateral retrograde approach, the stent allegedly dislodged.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint hstory review was performed.This is the second 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 physical sample was returned for evaluation.The stent and sleeve were returned, the lifestream catheter was not returned.The stent was returned lodged within the sleeve.There was no visible damage on the sleeve or stent.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 received from the field communications, sample evaluation and image review.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.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.Directions for use 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.6.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.Storage store in a cool, dry place.Keep away from sunlight.H10: d4 (expiration date: 07/2024),.

• 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: 16143316
• Report Number: 9616666-2022-00275
• Device Sequence Number: 6669414
• Product Code: PRL
• UDI-Device Identifier: 05391522081093
• UDI-Public: (01)05391522081093
• 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
• Report Date (Section B): 02/10/2023

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 Model Number: LSMU0800726
• Device Catalogue Number: LSMU0800726
• Device Lot Number: CMFV0359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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