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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 LSM0800938
Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2018
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 04/2021).
 
Event Description
It was reported that during a four vessel tevar procedure for renals sma and celiac, the balloon expandable covered stent allegedly became stuck in the 8f 55 cm introducer sheath and dislodged from the delivery system.Another device was used to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during a four vessel tevar procedure for renals sma and celiac, the balloon expandable covered stent allegedly became stuck in the 8f 55 cm introducer sheath and dislodged from the delivery system.Another device was used to complete the procedure.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 investigation is inconclusive for the reported stent dislodgment and device compatibility issues.The stent & sheath were not returned and the balloon appeared to have been inflated.The definitive root cause for the reported issues could not be determined based upon available information.The event description states that the lifestream was being used off label i.E.In a four vessel tevar procedure.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.It is unknown if there were patient factors, procedural or handling techniques that contributed to the reported event.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product 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 in the renal artery in a four vessel tevar procedure.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 04/2021).(method 1, results 1).
 
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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 Key8076124
MDR Text Key127865528
Report Number9616666-2018-00163
Device Sequence Number1
Product Code PRL
UDI-Device Identifier05391522081666
UDI-Public(01)05391522081666
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 01/09/2019
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 NumberLSM0800938
Device Lot NumberCMCS0256
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2018
Initial Date Manufacturer Received 10/19/2018
Initial Date FDA Received11/15/2018
Supplement Dates Manufacturer Received01/04/2019
Supplement Dates FDA Received01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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