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

Catalog Number LSM0800626

Device Problems Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/20/2017

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.Receipt of device is expected.The investigation is currently in progress.

Event Description

It was reported that the stent dislodged inside the patient.The device was used for a complex aortic aaa procedure.During insertion through the sheath the physician felt resistance force.The target area for stent deployment could not be reached and therefore a decision was made to remove the device without deployment.During removal the stent was dislodged from the balloon and it was lost in the vessel.It was thought that the stent was probably lost at the tip of the sheath.The stent was retracted using a snare.The patient was not injured during the procedure.

Manufacturer Narrative

It was reported that the stent dislodged inside the patient.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover.The device was used for a complex aortic aaa procedure.During insertion through the sheath the physician felt resistance force.The target area for stent deployment could not be reached and therefore a decision was made to remove the device without deployment.The device was attempted to be pulled back through the sheath to remove it and during removal the stent dislodged from the balloon and was lost in the vessel.It was thought that the stent was probably lost at the tip of the sheath.The stent was retracted using a snare.The patient was not injured during the procedure.The lot history records have been reviewed with special attention to the manufacturing and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.There have been no other complaints reported of any type for this lot number.The device was returned for evaluation.External packaging was returned.No internal packaging was returned.The hub was printed as expected and no visual defects were noted.The stent guard was not returned.No visual defects were noted on the distal tip or inner.The outer was damaged in a ribbed effect for a length of approx.170mm.The damage commenced 360mm from the hub.The stent arrived back separate from the device.It was noted that the stent was damaged at one end.The damage most likely occurred during its removal from the patient when a snare was used.No visual damage was noted on the balloon.There was evidence that the balloon had been inflated and crimp marks were evident along the length of the balloon.No functional examination was carried out on the device as the dislodgment failure mode was already confirmed.The result of the investigation is confirmed.However the event description outlines that the stent was used in a complex aortic aaa procedure.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries as per the ifu.Also the ifu, document states: "attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent." it is likely that use of the device off label was a contributing factor in the reported event.Based upon the available information a definitive root cause cannot be determined.It is also unknown whether patient factors handling or other procedural techniques 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 0.07% (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 dec 17 is 0.02%.While this figure is slightly higher than the predicted rate of 0.01% this calculation is based on 16 months of sales which is less than the required 24 months.If the calculation is adjusted for 24 months sales the rate is 0.01% which is equal to 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.

Event Description

It was reported that the stent dislodged inside the patient.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover.The device was used for a complex aortic aaa procedure.During insertion through the sheath the physician felt resistance force.The target area for stent deployment could not be reached and therefore a decision was made to remove the device without deployment.The device was attempted to be pulled back through the sheath to remove it and during removal the stent dislodged from the balloon and was lost in the vessel.It was thought that the stent was probably lost at the tip of the sheath.The stent was retracted using a snare.The patient was not injured during the procedure.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7203281
• MDR Text Key: 97663799
• Report Number: 9616666-2018-00002
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: LSM0800626
• Device Lot Number: CMBQ0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention