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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 LSM1351238
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo is provided for a review.The investigation of the reported event is currently underway.The catalog number identified in section has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510k number for the lifestream products are identified.(expiry date: 09/2022).
 
Event Description
It was reported that during treatment of the right external iliac aneurysm, the stent was allegedly stuck inside the introducer.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified in d2 and g5.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Investigation summary: the sample is not available for return.However, six images were provided and reviewed.Three images revealed of carton and pouch labelling confirming lot number used in the medical procedure.Another three images showing a badly deformed bloody stent held by a hcp.The stent appears to be partially expanded at one end.The size of the stent cannot be confirmed.The result of the investigation is inconclusive for the reported device incompatibility issue.The root cause for the reported device incompatibility issue could not be determined based upon the available information received from the field communications and images provided.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: the event description states that the lifestream was being used to treat an aneurysm in the right iliac 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: d4 (expiry date: 09/2022), g4 h11: h6 (results and conclusion) 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 Description
It was reported that during treatment of the right external iliac aneurysm, the stent was allegedly stuck inside the introducer.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination; therefore, a device history record review is not required.Investigation summary: the sample is not available for return.However, six images were provided and reviewed.Three images revealed of carton and pouch labelling confirming lot number used in the medical procedure.Another three images showing a badly deformed bloody stent held by a hcp.The stent appears to be partially expanded at one end.The size of the stent cannot be confirmed.The result of the investigation is inconclusive for the reported device incompatibility issue.The root cause for the reported device incompatibility issue could not be determined based upon the available information received from the field communications and images provided.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: the event description states that the lifestream was being used to treat an aneurysm in the right iliac 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: (expiry date: 09/2022).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.H3 other text: device not returned.
 
Event Description
It was reported that during treatment of the right external iliac aneurysm, the stent was allegedly stuck inside the introducer.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
 
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Brand Name
LIFESTREAM
Type of Device
BALLOON EXPANDABLE VASCULAR COVERED STENT
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI  N A
MDR Report Key10768737
MDR Text Key214123999
Report Number9616666-2020-20013
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,distri
Type of Report Initial,Followup,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLSM1351238
Device Lot NumberCMDX0270
Was Device Available for Evaluation? No
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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