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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 Material Split, Cut or Torn (4008)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.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: 06/2021).
 
Event Description
It was reported that during a product demonstration for educational purposes, the health care provider used a 10cc syringe to attempt deploy the stent graft, and immediately post inflation the eptfe material allegedly tore across the entire length of the stent graft.There was no reported patient contact.
 
Event Description
It was reported that during a product demonstration for educational purposes, the health care provider used a 10cc syringe to attempt deploy the stent graft, and immediately post inflation the eptfe material allegedly tore across the entire length of the stent graft.There was no reported patient contact.
 
Manufacturer Narrative
Manufacturing review: a complaint lot history review was carried out for the reported lot number.The lot met all test release criteria.There was no anomalies identified and there was nothing found to indicate a manufacturing related cause for this event.This is the first reported complaint for this lot number and issue to date.Investigation summary: the investigation is confirmed for the material split, cut, torn failure mode reported.The ptfe coating on the stent was found to be torn / split for the entire length of the stent.The definitive root cause for the reported material split, cut or torn failure mode was likely due to the off label use of the device.The event description states that the lifestream was used in a product demonstration for educational purposes which was outside the body.It is understood these types of failures occur when stents are deployed dry (i.E.Not inside the body or are not conditioned to simulate deployment within a blood vessel).It is not recommended to deploy the device for demo unless it is preconditioned (simulating actual use environment).The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries (section b indication for use).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 and contains the following information relevant to the reported event: the event description states that the lifestream was used in a product demonstration for educational purposes which was outside the body.This is off label use.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries (section b indication for use).The catalog number identified in section d4 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 in d2 and g5.H11:section a through f - 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.
 
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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 Key8086919
MDR Text Key127865196
Report Number9616666-2018-00167
Device Sequence Number1
Product Code PRL
UDI-Device Identifier05391522081765
UDI-Public(01)05391522081765
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,user f
Type of Report Initial,Followup
Report Date 02/21/2019
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 Expiration Date06/30/2021
Device Catalogue NumberLSM1351238
Device Lot NumberCMCU0603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Initial Date Manufacturer Received 10/23/2018
Initial Date FDA Received11/19/2018
Supplement Dates Manufacturer Received02/04/2019
Supplement Dates FDA Received02/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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