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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 UNKNOWN LIFESTREAM
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
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.No medical records were provided; however x-rays were provided to the manufacturer and are under review.As the lot number for the device was not provided, a review of the device history records has not been performed.The device is not available for return.The investigation is currently underway.The information provided by bard 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 bard.
 
Event Description
It was reported that post stent graft fenestration stent treatment in an aortic stent graft procedure an endoleak was allegedly identified.It was further reported that additional medical intervention (re-treatment) was required to cover the endoleak by relining with another manufacturer's stent graft.There was no impact or consequence to the patient post intervention procedure.
 
Manufacturer Narrative
Note that the only other change is to the investigation summary.A complete manufacturing review could not be conducted, as the lot number was not reported for this device.Based on the images provided, contrast extravasation was demonstrated just superior to the hepatic and splenic artery bifurcation was confirmed.Based on the images provided, there was no contrast extravasation was demonstrated just superior to the hepatic and splenic artery bifurcation post stent deployment was confirmed.The result of the investigation is confirmed.Images supplied of the condition confirmed that contrast extravasation was demonstrated just superior to the hepatic and splenic artery bifurcation.The sample was not returned for evaluation.The definitive root cause for the reported endoleak issue could not be determined based upon available information however it is likely that the use of the device off label was the contributing factor in the reported event.The event description outlines that the stent was used in an aortic stent graft process procedure.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.The ifu for the lifestream product was reviewed for information relevant to the reported event: the event description outlines that the stent was used in an aortic stent graft process 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.
 
Event Description
It was reported that post stent graft fenestration stent treatment in an aortic stent graft procedure an endoleak was allegedly identified.It was further reported that additional medical intervention (re-treatment) was required to cover the endoleak by relining with another manufacturer's stent graft.There was no impact or consequence to the patient post intervention procedure.
 
Event Description
It was reported that post stent graft fenestration stent treatment in an aortic stent graft procedure an endoleak was allegedly identified.It was further reported that additional medical intervention (re-treatment ) was required to cover the endoleak by relining with another manufacturer's stent graft.There was no impact or consequence to the patient post intervention procedure.
 
Manufacturer Narrative
A complete manufacturing review could not be conducted, as the lot number was not reported for this device.The result of the investigation is confirmed.Two x-rays supplied for clearstream review appear to show the endoleak as described in the event description.The sample was not returned for evaluation.The definitive root cause for the reported endoleak issue could not be determined based upon available information however it is likely that the use of the device off label was the contributing factor in the reported event.The event description outlines that the stent was used in an aortic stent graft process procedure.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.The ifu for the lifestream product was reviewed for information relevant to the reported event: the event description outlines that the stent was used in an aortic stent graft process 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.(b)(4).
 
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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 Key7908305
MDR Text Key121707948
Report Number9616666-2018-00139
Device Sequence Number1
Product Code PRL
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,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN LIFESTREAM
Was Device Available for Evaluation? No
Date Manufacturer Received11/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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