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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 LSM1350938
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2017
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: the lot number has been 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 reported for this lot number and issue to date.Investigation summary: an evaluation was not performed as the device was not returned.The result of the investigation is inconclusive.The sample was not returned for evaluation.Based upon the available information a definitive root cause cannot be determined.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: (b)(6) 2021); (manufacturing date: (b)(6) 2014).
 
Event Description
It was reported through the results of a clinical trial that follow up imaging at 24 and 36 months identified instent stenosis.No reported intervention was performed.The current patient status is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a complaint lot history review was carried out.The production history for the device was reviewed and no anomalies were identified.The lot met all test release criteria.Nothing was 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 reported instent stenosis issue.The device was not returned for evaluation.The definitive root cause for the reported instent stenosis issue could not be determined based upon available information.While imaging at 24 and 36 months identified instent stenosis, it was not proven that the lifestream device was responsible.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.It is unknown whether the patient factors, handling, procedural techniques or disease progression contributed to the reported event.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: potential adverse events ¿ arterial occlusion/restenosis of the treated vessel ¿ restenosis in the treatment area / covered stent edge (expiration date: 02/2021), (manufacturing date: 10/2014).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.
 
Event Description
It was reported through the results of a clinical trial that follow up imaging at 24 and 36 months identified instent stenosis.No reported intervention was performed.The current patient status is unknown.
 
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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 Key7866875
MDR Text Key119941784
Report Number9616666-2018-00130
Device Sequence Number1
Product Code PRL
UDI-Device Identifier05391522081680
UDI-Public(01)05391522081680
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 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLSM1350938
Device Lot Number50115545
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ASPIRIN, CLOPIDOGREL
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