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

Catalog Number UNKNOWN LIFESTREAM US

Device Problem Folded (2630)

Patient Problem Thrombus (2101)

Event Date 10/06/2017

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 not expected.The investigation is currently in progress.Device not returned.

Event Description

It was reported that the stent crimped and there was thrombus.There were two devices that reportedly crimped and were thrombus.Reportedly both renal stents "crimped" and thrombosed on both sides.The procedure was chimney aaa procedure.The two devices were prepped, handled and implanted in accordance with the ifu.The devices were deployed and implanted correctly in the vessel during the initial procedure.There were no failures with the devices in the initial procedure and the procedure seemed to be successful.However, the patient returned to the hospital with complications.The proximal portions of the complaint device and the other lifestream device were in the aorta and the rest of the devices were in the renal arteries.The stents crimped and there was thrombus.Reportedly the doctor stated that they think the blood flow had compressed the proximal portion of the stents and the devices did not have enough radial strength to withhold the pressure.The thrombus had to be suctioned out and icast was used inside the stents for reinforcement.Other than being old and frail the patient does not have any condition that could have contributed to the failures.The doctor was aware that the devices were used outside of the indications for use.The patient is in the intensive care unit currently.

Event Description

It was reported that the stent crimped and there was thrombus.There were two devices that reportedly crimped and were thrombus.Reportedly both renal stents "crimped" and thrombosed on both sides.The procedure was chimney aaa procedure.The two devices were prepped, handled and implanted in accordance with the ifu.The devices were deployed and implanted correctly in the vessel during the initial procedure.There were no failures with the devices in the initial procedure and the procedure seemed to be successful.However, the patient returned to the hospital with complications.The proximal portions of the complaint device and the other lifestream device were in the aorta and the rest of the devices were in the renal arteries.The stents crimped and there was thrombus.The thrombus had to be suctioned out and icast was used inside the stents for reinforcement.Other than being old and frail the patient does not have any condition that could have contributed to the failures.The doctor was aware that the devices were used outside of the indications for use.The patient is in the intensive care unit currently.

Manufacturer Narrative

It was reported that the stent crimped and there was thrombus.There were two devices that reportedly crimped and were thrombus.Reportedly both renal stents "crimped" and thrombosed on both sides.The procedure was chimney aaa procedure.The two devices were prepped, handled and implanted in accordance with the ifu.The devices were deployed and implanted correctly in the vessel during the initial procedure.There were no failures with the devices in the initial procedure and the procedure seemed to be successful.However, the patient returned to the hospital with complications.The proximal portions of the complaint device and the other lifestream device were in the aorta and the rest of the devices were in the renal arteries.The stents crimped and there was thrombus.The thrombus had to be suctioned out and icast was used inside the stents for reinforcement.Other than being old and frail the patient does not have any condition that could have contributed to the failures.The doctor was aware that the devices were used outside of the indications for use.The patient is in the intensive care unit currently.The lot history records could not be reviewed as the lot number is unknown.The device was not returned for evaluation.The result of the investigation is confirmed.The sample was not returned for evaluation.However the event description outlines that the stent was used in a chimney aaa procedure.A review of the cd supplied appeared to confirm stent positioning within the aorta and renal arteries.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries (section b indication for use).The event also states that the doctor was aware that the devices were used outside of the indications for use.The doctor stated that the blood flow had compressed the proximal portion of the stents and the devices did not have enough radial strength to withhold the pressure.Based upon the available information it is likely that use of the devices off label was the contributing factor in the reported event.Based on analysis performed no additional action is required at this time.Finally the complaint rate for the occlusion failure mode is 0.03% and exceeds the predicted rate of 0.01%.Therefore an event has been raised in our quality system to address this issue.The ifu states: 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.(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
• MDR Report Key: 7028474
• MDR Text Key: 91940390
• Report Number: 9616666-2017-00126
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: UNKNOWN LIFESTREAM US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 50