MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM; BALLOON EXP[ANDABLE VASCULAR COVERED STENT

Catalog Number LSM1350758

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2017

Event Type  Injury  

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.The device is expected to be returned.The investigation is on-going.Not returned.

Event Description

It was reported that the stent became detached from the balloon prior to actual deployment.There was no reported patient injury.

Manufacturer Narrative

It was reported that the stent became detached from the balloon inside the patient prior to deployment.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover and no difficulty removing the stent cover.The target lesion was the left renal artery.The target lesion was tortuous.The patient was being treated for stenosis.The doctor tried to navigate the complaint device from where the sheath tip was positioned to the lesion which was around 10cm distal to the sheath tip.There was difficulty advancing the device through the lesion and therefore the device was attempted to be retracted back into the sheath for removal.The stent then dislocated from the device inside the patient.It was noticed that the stent had dislocated from the device when the device was examined on the table following the extraction through the sheath.The stent was still over the wire so it was able to be removed from the patient using a snare.The stent graft was not protected by the sheath during all steps of tracking to the lesion.Air evacuation and pre-dilatation was not performed.Multiple attempts to insert the device into the sheath were not required.Guidewire access was maintained throughout the procedure.The procedure was not completed and was abandoned.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 event reported for this lot number and issue to date.The device was returned for evaluation.External and internal packaging was not returned.The hub was printed as expected and there were no visual defects noted.The stent and stent guard were not returned.No visual defects were noted on the tip or shaft.There was evidence of dried substance on the shaft at the proximal bond.No functional examination was carried out due as this was not applicable to the reported complaint.The evaluation of the retuned device is inconclusive for the dislodgement failure mode reported.User error may have contributed to the reported issue.The event description stated there was difficulty advancing the device through the lesion and that the device was attempted to be retracted back into the sheath for removal.This is contrary to what is directed in the ifu.This action may have caused the stent to move.The ifu states: "do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter.Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement".Based on analysis performed no additional action is required at this time.However a capa has been raised to address stent dislodgement issues which have been reported 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 cc¿s 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 became detached from the balloon inside the patient prior to deployment.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover and no difficulty removing the stent cover.The target lesion was the left renal artery.The target lesion was tortuous.The patient was being treated for stenosis.The doctor tried to navigate the complaint device from where the sheath tip was positioned to the lesion which was around 10cm distal to the sheath tip.There was difficulty advancing the device through the lesion and therefore the device was attempted to be retracted back into the sheath for removal.The stent then dislocated from the device inside the patient.It was noticed that the stent had dislocated from the device when the device was examined on the table following the extraction through the sheath.The stent was still over the wire so it was able to be removed from the patient using a snare.The stent graft was not protected by the sheath during all steps of tracking to the lesion.Air evacuation and pre-dilatation was not performed.Multiple attempts to insert the device into the sheath were not required.Guidewire access was maintained throughout the procedure.The procedure was not completed and was abandoned.There was no reported patient injury.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXP[ANDABLE 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 Key: 6720669
• MDR Text Key: 80435680
• Report Number: 9616666-2017-00048
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: LSM1350758
• Device Lot Number: 50137478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention