MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM; BALLOON EXPANDABLE VASCULAR COVERED STENT

Catalog Number LSMU1351058

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2017

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 not expected to be returned.The investigation is on-going.

Event Description

It was reported that the stent dislodged as it was going through the 8fr terumo sheath.The target lesion was the right femoral artery.The stent dislodged when being advanced through the 8f introducer sheath.The health care provider snared out the dislodged stent successfully without losing access, and used a second device to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

It was reported that the stent dislodged as it was going through the 8fr terumo sheath.The target lesion was the right femoral artery.The stent dislodged when being advanced through the 8f introducer sheath.The health care provider snared out the dislodged stent successfully without losing access, and used a second device to complete the procedure.There was no reported patient injury.The lot history records could not be reviewed as the lot number was unknown.The device was not returned for evaluation.The result of the investigation is inconclusive as no sample returned for evaluation.The event information described that the target lesion for the lifestream device was the right femoral artery.This indicates that the device was been used off label.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.Based upon the available information a definitive root cause has not been determined.It is also unknown if patient factors, handling or procedural techniques may have contributed to the reported event.Based on analysis performed no additional action is required at this time.Note: while the current confirmed calculated rate for this failure mode is 0.073% (last 24 months) and is hence higher than the predicted rate of 0.01% the rate is decreasing since the process improvement (action from capa) was introduced into production during sept 16.The current rate from sept 16 to aug 17 is 0.016%.While this figure is slightly higher than the predicted rate of 0.01% this calculation is based on 12 months of sales which is less than the required 24 months.If the calculation is adjusted for 24 months sales the rate is 0.009% which is below the predicted rate.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).

• 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 Key: 6885729
• MDR Text Key: 87213070
• Report Number: 9616666-2017-00084
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSMU1351058
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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