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

Model Number	LSMU1350626
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review 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.(expiry date: 04/2020).
Event or Problem Description
It was reported that after the healthcare provider (hcp) made multiple attempts to advance the delivery system through the tortuous renal artery, the delivery system successfully arrived at the target lesion and deployment was attempted; however, the stent graft allegedly dislodged from the delivery system.It was further reported that the stent graft was retrieved.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the investigation is inconclusive for the reported dislodgement issue.The sample was not returned for evaluation.The root cause for the reported dislodgement issue could not be determined based upon the available information received from the field communications.The event description states that the lifestream device was being used in the tortuous renal artery.This is off label use of the device.It is likely that the patient factors and the multiple attempts to advance the delivery system through the tortuous renal artery contributed to the reported event.Labeling review: the ifu for the lifestream product was reviewed for information relevant to the reported event: the event description states that the lifestream device was being used in the renal artery.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.H10: b5, d4(expiry date: 04/2020), g4.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 after the healthcare provider (hcp) made multiple attempts to advance the delivery system through the tortuous renal artery, the delivery system successfully arrived at the target lesion and deployment was attempted; however, the stent graft allegedly dislodged from the delivery system.It was further reported that the stent graft was retrieved.Air evacuation was allegedly not performed before the procedure.There was no reported patient injury.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9914359
• Report Number: 9616666-2020-00023
• Device Sequence Number: 3354937
• Product Code: PRL
• UDI-Device Identifier: 05391522081055
• UDI-Public: (01)05391522081055
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P160024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: LSMU1350626
• Device Catalogue Number: LSMU1350626
• Device Lot Number: CMBS0370
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1