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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
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CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT Back to Search Results
Catalog Number LSM1350537
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2019
Event Type  malfunction  
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.The catalog number identified has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stent products are identified.(expiry date 12/2020).
 
Event Description
It was reported that during a stent deployment procedure to treat an aneurysm of the bifurcation of the renal artery, the balloon expandable vascular covered stent allegedly dislodged from the balloon just prior to deployment.It was further reported that the covered stent was left in the artery and does not pose any consequence to the patient and there are no plans to remove it.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the result of the investigation is inconclusive for the stent dislodgment failure mode reported.While two images were provided for review; image 1.Jpg appeared to show a partially expanded stent.However the dislodgment issue could not be proven as the catheter was not returned for evaluation.The definitive root cause for the reported stent dislodgment issue could not be determined based upon available information.The event description states that the lifestream device was being used to treat an aneurysm of the bifurcation of 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.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue it is unknown if patient factors or handling techniques were factors in the reported issue.Labeling review: the ifu for the lifestream product was reviewed for information relevant to the reported event: the event description states that the lifestream was being used to treat an aneurysm of the bifurcation of 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.(expiry date 12/2020).
 
Event Description
It was reported that during a stent deployment procedure to treat an aneurysm of the bifurcation of the renal artery, the balloon expandable vascular covered stent allegedly dislodged from the balloon just prior to deployment.It was further reported that the covered stent was left in the artery and does not pose any consequence to the patient and there are no plans to remove it.There was no reported patient injury.
 
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Brand Name
LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
Type of Device
BALLOON EXPANDABLE VASCULAR COVERED STENT
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI 
MDR Report Key8336175
MDR Text Key136994256
Report Number9616666-2019-00010
Device Sequence Number1
Product Code PRL
UDI-Device Identifier05391522081413
UDI-Public(01)05391522081413
Combination Product (y/n)N
PMA/PMN Number
P160024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLSM1350537
Device Lot NumberCMCN0215
Was Device Available for Evaluation? No
Date Manufacturer Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 DA
Patient Weight100
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