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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
Model Number LSMU0800726
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2018
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 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 during a first time intervention via an ipsilateral right common femoral approach to treat a very calcified iliac lesion for a patient with abnormal brachial index (abi), the balloon expandable vascular covered stent catheter allegedly failed to load through a 6fr introducer sheath.Therefore, the catheter was removed without incident from the patient, and a 6x37 balloon expandable vascular covered stent catheter was used to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during a first time intervention via an ipsilateral right common femoral approach to treat a very calcified iliac lesion for a patient with abnormal brachial index (abi), the balloon expandable vascular covered stent catheter allegedly failed to load through a 6fr introducer sheath.Therefore, the catheter was removed without incident from the patient, and a 6x37 balloon expandable vascular covered stent catheter was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the lot number was 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.Investigation summary: the investigation was unconfirmed for the reported device incompatibility failure mode.The device successfully passed through the sheath during the evaluation.Based on the available information a definitive root cause cannot be determined.It is unknown if there were procedural or handling techniques that 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: a device description 1.Implant the lifestream¿ balloon expandable vascular covered stent is comprised of an electropolished balloon-expandable stent made from 316l stainless steel, encapsulated between two layers of eptfe.B indication for use the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Directions for use site access and preparation 1.Using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.2.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Covered stent size selection 3.Select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.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.6.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.Air evacuation 7.A 20 cc or smaller luer-lock syringe with a minimum of 5 cc¿s sterile saline mixture is recommended for use for aspirating this device.8.With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.9.Induce a negative pressure to remove any air from the balloon and inflation lumen.Repeat until all air is expelled.10.Carefully release to neutral.Allow the inflation lumen to fill with the diluted contrast medium and maintain a neutral pressure.Important: do not apply positive pressure to the balloon.11.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.12.Verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter.Introduction of the endovascular system and placement of the covered stent 13.Advance the endovascular system over the guidewire into the introducer sheath.14.Further advance the endovascular system to the target treatment site within the introducer sheath and position the covered stent across the lesion.Verify that the covered stent is still centered within the balloon marker bands.Slowly retract the introducer sheath / guiding catheter while maintaining the position of the covered stent.Ensure the introducer sheath is retracted far enough to not compromise the balloon expansion and covered stent release.
 
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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 Key7672145
MDR Text Key113510610
Report Number9616666-2018-00092
Device Sequence Number1
Product Code PRL
UDI-Device Identifier05391522081093
UDI-Public(01)05391522081093
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 08/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLSMU0800726
Device Catalogue NumberLSMU0800726
Device Lot NumberCMBQ0227
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Date Manufacturer Received07/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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