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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM BALLOON EXPANDABLE COVERED STENT
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CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM BALLOON EXPANDABLE COVERED STENT Back to Search Results
Model Number LSMU1350637
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 08/06/2018
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 under way.(expiration date: 05/2020).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 during preparation, the covered stent allegedly detached during removal of the stent guard from the balloon catheter.Reportedly, another balloon expandable covered stent was used to complete the procedure.There was no patient contact.
 
Manufacturer Narrative
Manufacturing review: 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.Investigation summary: the result of the investigation has confirmed the stent dislodgement failure mode reported.The stent dislodged from the balloon and remained lodged within the stent guard when the sleeve was removed during the evaluation.The definitive root cause for the reported issue could not be determined based upon available information.It is unknown whether handling or other procedural techniques 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 review of the lifestream ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.The following addresses the reported issue in section m: endovascular system preparation 4.Carefully remove the selected device from the package.5.Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.D4 - expiry date: may / 2020.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 that during preparation, the covered stent allegedly detached during removal of the stent guard from the balloon catheter.Reportedly, another balloon expandable covered stent was used to complete the procedure.There was no patient contact.
 
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Brand Name
LIFESTREAM BALLOON EXPANDABLE COVERED STENT
Type of Device
BALLOON EXPANDABLE COVERED STENT
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI 
MDR Report Key7838534
MDR Text Key119346331
Report Number9616666-2018-00122
Device Sequence Number1
Product Code PRL
UDI-Device Identifier05391522081062
UDI-Public(01)05391522081062
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,health
Type of Report Initial,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLSMU1350637
Device Catalogue NumberLSMU1350637
Device Lot NumberCMBT0008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
Date Manufacturer Received10/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
Patient Weight70
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