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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 LSMU1350726
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/27/2017
Event Type  malfunction  
Manufacturer Narrative
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.Receipt of device is expected.The investigation is currently in progress.
 
Event Description
It was reported that the stent dislodged inside of the sheath.A 90 cm, 6fr, terumo destination sheath was used.The device was delivered to the deployment site, passing through the entirety of the sheath.However upon inspection, dr.(b)(6) judged that the stent needed to be placed in a different position, which called for a different sheath position.Therefore, the complaint device unit was then withdrawn out of the patient fully intact.The sheath was repositioned and the complaint device was re-delivered.Once out of the distal end of the sheath, it was noted the stent-graft was no longer mounted on the balloon.An angiographic image showed the stent graft lodged inside the distal portion of the sheath.The sheath was withdrawn and the stent was retrieved.A second sheath, this time a 6.5 fr medtronic steerable tourguide sheath was selected and placed.A second lifestream device was to be used.However, again the stent-graft was found dislodged from the balloon and lodged in the distal portion of the sheath, confirmed under fluoroscopy.The stent was withdrawn and the stent graft was retrieved.A bare metal express stent was then selected and placed in the treatment site.There was no reported patient injury.
 
Manufacturer Narrative
It was reported that the stent dislodged inside of the sheath.A 90cm, 6fr, terumo destination sheath was used.The target lesion was the coronary artery close to aortic arch.Access was made via the common femoral artery.The target lesion was tortuous.Pre-dilatation was performed.The device was delivered to the deployment site, passing through the entirety of the sheath.However upon inspection, dr.(b)(6) judged that the stent needed to be placed in a different position, which called for a different sheath position.Therefore, the complaint device unit was then withdrawn out of the patient fully intact.The sheath was repositioned and the complaint device was re-delivered.Once out of the distal end of the sheath, it was noted the stent-graft was no longer mounted on the balloon.An angiographic image showed the stent graft lodged inside the distal portion of the sheath.The device was withdrawn with the sheath and the stent was retrieved.Air evacuation was not performed.Resistance was felt when tracking the device.The stent was protected by the sheath when tracking.The delivery system was pulled back into the sheath during the procedure.A second sheath, this time a 6.5fr medtronic steerable tour guide sheath was selected and placed.A second lifestream device was to be used.However, again the stent-graft was found dislodged from the balloon and lodged in the distal portion of the sheath, confirmed under fluoroscopy.The stent was withdrawn and the stent graft was retrieved.A bare metal express stent was then selected and placed in the treatment site.Guidewire access was maintained throughout the procedure.There was no reported patient injury.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.This is the first reported complaint for this lot number and issue to date.The device was returned for evaluation.External and internal packaging was returned.The hub was printed as expected and there were no visual defects noted.The stent guard was not returned with the device.No visual defects were noted on the tip, outer or inner.The stent was returned separate to the device, the stent was bowed/curved.There was no other damage noted.No damage was observed on the balloon.There was evidence of crimp markings on the balloon between the two markerbands.No functional examination was carried out on the device as it was not applicable to the complaint.The result of the investigation is confirmed.The evaluation of the returned device has confirmed the stent dislodged failure mode reported.The stent was returned separate to the device.The balloon had not been inflated.However user error / procedural techniques may have been contributing factors.Air evacuation was not performed.The event description also states that the "complaint device unit was then withdrawn out of the patient fully intact.The sheath was repositioned and the complaint device was re-delivered".This is contrary to what is directed in the ifu.The ifu states "do not attempt to remove an unexpanded covered stent through the sheath /guiding catheter".Based upon the available information a definitive root cause cannot be determined.Based on analysis performed no additional action is required at this time.(b)(4).The ifu states: a device description: 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.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: 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.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Covered stent size selection.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.Carefully remove the selected device from the package.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.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.Air evacuation: a 20 cc or smaller luer-lock syringe with a minimum of 5 ccs sterile saline mixture is recommended for use for aspirating this device.With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.Induce a negative pressure to remove any air from the balloon and inflation lumen.Repeat until all air is expelled.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.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.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.Advance the endovascular system over the guidewire into the introducer sheath.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.(b)(4).
 
Event Description
It was reported that the stent dislodged inside of the sheath.A 90cm, 6fr, terumo destination sheath was used.The target lesion was the coronary artery close to aortic arch.Access was made via the common femoral artery.The target lesion was tortuous.Pre-dilatation was performed.The device was delivered to the deployment site, passing through the entirety of the sheath.However upon inspection, dr.(b)(6) judged that the stent needed to be placed in a different position, which called for a different sheath position.Therefore, the complaint device unit was then withdrawn out of the patient fully intact.The sheath was repositioned and the complaint device was re-delivered.Once out of the distal end of the sheath, it was noted the stent-graft was no longer mounted on the balloon.An angiographic image showed the stent graft lodged inside the distal portion of the sheath.The device was withdrawn with the sheath and the stent was retrieved.Air evacuation was not performed.Resistance was felt when tracking the device.The stent was protected by the sheath when tracking.The delivery system was pulled back into the sheath during the procedure.A second sheath, this time a 6.5fr medtronic steerable tourguide sheath was selected and placed.A second lifestream device was to be used.However, again the stent-graft was found dislodged from the balloon and lodged in the distal portion of the sheath, confirmed under fluoroscopy.The stent was withdrawn and the stent graft was retrieved.A bare metal express stent was then selected and placed in the treatment site.Guidewire access was maintained throughout 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
EI 
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI  
Manufacturer Contact
fiona nimhullain
539237111
MDR Report Key6969088
MDR Text Key90780369
Report Number9616666-2017-00111
Device Sequence Number1
Product Code PRL
UDI-Device Identifier05391522081130
UDI-Public(01)05391522081130
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/05/2017
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 Date06/30/2020
Device Model NumberLSMU1350726
Device Catalogue NumberLSMU1350726
Device Lot NumberCMBU0384
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2017
Is the Reporter a Health Professional? No
Event Location Hospital
Initial Date Manufacturer Received 10/04/2017
Initial Date FDA Received10/23/2017
Supplement Dates Manufacturer Received10/31/2017
Supplement Dates FDA Received12/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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